Dr. Joe W. Gray
MS 84R0171
1 Cyclotron Road
Berkeley, CA 94720-
Phone: 510-486-2438
Fax: 510-486-2535
E-mail: jwgray@lbl.gov
Number of Human Subjects projects reported: 36
| LBNL-75-001-H02 | "Experimental Medicine Clinical" |
| LBNL-77-057-H02 | "Studies of Lipoproteins and Lipid Protein Interactions" |
| LBNL-79-106-H02 | "Lipoproteins and Atherogenesis in Transgenic Animals" |
| LBNL-79-108-H01 | "Characterization of Human Mammary Cells" |
| LBNL-80-001-H01 | "Myocardial Flow, Function, and Metabolism by PET & MRI " |
| LBNL-84-001-H03 | "Alzheimer's Disease as a Systemic Disorder" |
| LBNL-91-107-H01 | "National Runners and Walkers Health Study" |
| LBNL-92-106-H04 | "Genes Affecting Metabolic Responses to Dietary Fat and Carbohydrates (Formerly, Genetic and Metabolic Factors Affecting Response of Lp(a) to Dietary Fat) " |
| LBNL-92-107-H05 | "Gene Specific Responses to Exercise in Discordant Twins (Formerly, "Effects of Running on HDL and LDL Subclasses of MZ Twins")" |
| LBNL-94-093-H01 | "Modulation of Oxidant Stress-Mediated Atherosclerosis " |
| LBNL-98-106-H06 | "Genetic Testing for Evaluation of Heart Disease Risk" |
| LBNL-98-107-H06 | "National Health Survey on the Internet" |
| LBNL-98-139-H01 | "Breast Cancer Specific PET Instrumentation" |
| LBNL-99-107-H07 | "Effects of Genes on the Relationship of Lifestyle to Disease" |
| LBNL-00-005-H01 | "Training in Mammary Gland Biology and Breast Cancer" |
| LBNL-00-106-H09 | "Arterial Endothelial Function: An Epidemiological Study" |
| LBNL-01-063-H01 | "Estrogen Receptors in the Brain" |
| LBNL-01-106-H13 | "Comparative Genomic Analysis of Cardiovascular Gene Regulation" |
| LBNL-01-109-H02 | "Indoor Bioaerosol Detection and Quantification by Polymerase Chain Reaction (PCR)" |
| LBNL-01-179-H01 | "Fast Identification of Lipoprotein Particles" |
| LBNL-01-180-H01 | "The Normal Magnetocardiogram (MCG): Spectrum of Findings with Rest and Exercise" |
| LBNL-02-106-H15 | "Pharmacogenetic Network for Cardiovascular Risk Therapy" |
| LBNL-02-106-H16 | "Dairy Research Institute for Genetics and Nutrition" |
| LBNL-02-107-H08 | "Validating Dietary Assessment on the Internet" |
| LBNL-02-109-H03 | "Thermal Comfort of a Task Ventilation System (Formerly, “Task Ventilation Optimization”)" |
| LBNL-02-180-H02 | "A Pilot Study of the Magnetocardiogram (MCG) of Cardiac Patients with Angina Pectoris and Known Heart Disease" |
| LBNL-02-185-H01 | "Breast Cancer and Environmental Risk Factors in Marin County - Pilot Study Phase I and Phase II" |
| LBNL-02-186-H01 | "Chelation Therapy Using Calcium DTPA and/or Zinc DTPA for Internal Contamination with Plutonium and Other Transuranic Elements" |
| LBNL-03-05H21 | "Undergraduate Training in Mammary Gland Biology and Breast Cancer" |
| LBNL-03-130H04 | "Nu 99G8: The National Ovarian Cancer Early Detection Program - Molecular Cytogenetic Detection of Early Cancer" |
| LBNL-03-184H02 | "Improved Cardiac SPECT with Convergent Hole Collimators" |
| LBNL-03-193H01 | "Ergo Arm Support Research and Development - Phase II: Field Testing and Engineering Prototype Refinement" |
| LBNL-03-194H01 | "Advanced Techniques in Latent Fingerprint Detection, Visualization and Analysis" |
| LBNL-03-207H01 | "Advancing Electrochromic Windows" |
| LBNL-03-85H04 | "Evaluation of Iodorotenone, a SPECT Perfusion Tracer" |
| LBNL-03-99H01 | "Role of CYP1B1 in PAH-DNA Adduct Formation and Breast Cancer" |
"Experimental Medicine Clinical"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1975
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 9
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/18/02
IRB approval number: 2002-10-41
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: PET Study of Breast Cancer
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic breast cancer. The LBNL procedures are to be applied twice, once during the initial visit, then two to four months following this initial scan. The subject may benefit from the detection of the presence of metastasis. Society may benefit from an improved technique for the diagnosis and management of future breast cancer patients.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to four months following the initial scan to evaluate progression of the disease for subjects off therapy or therapeutic response for subjects who are receiving therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/18/02
IRB approval number: 2002-10-42
Explanation of IRB approval:
This protocol was discontinued in August 2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 10/01/02 to 08/26/03
Explanation:
This protocol was discontinued in August of 2003.
Type(s) of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the viability of the heart muscle. The current trial is aimed at determining which patients with a negative diagnosis by a thallium perfusion study have a positive diagnosis for reversible disease by FDG. The benefit of this study to the subject and future individuals with damaged heart muscle is reversibility.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising, faintness); radiation (equivalent to a back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
This protocol was discontinued in August 2003.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/16/03
IRB approval number: 2003-4-60
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: "Assessment of Maximum Vasiodilatory Reserve and Sensitivity to Ischemia"
OBJECTIVES
The purpose of this study is to evaluate a measure of vasodilatory reserve and sensitivity to ischemia. The method will be evaluated before and after consumption of nicotine or meals of varying composition.
METHODOLOGY
Up to 60 male and female subjects will be recruited by posting advertisements in local newspapers. Half will be assigned to Group 1 (nicotine study) and half to Group 2 (diet study). Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Both groups will fast for 12 hours before being in the study. Subjects in Group 1 will participate up to ten times, and subjects in Group 2 five times.
Core Procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 'O' seconds. The sound of the artificial pulse will be recorded before, during, and for 'M' minutes after the blood pressure cuff is released using a laser Doppler imager. The cuff will be tightened and released three times during each procedure; each cycle of tightening will be longer than the previous one. The value of 'O' will vary from 15 to 300 seconds, and 'M' from 30 to 120 seconds.
Group 1: Subjects will fast for 12 hours before each study. On the day of the study, each subject will receive a brief medical screening. The subject will then have a set of measurements taken use the Core Procedure, will chew nicotine polacrilex gum for about thirty minutes, then have a second set of Core measurements. The dose of nicotine will be similar to or less than used for smoking cessation.
Group 2: Subjects will fast for 12 hours before each study. On the day of the study, each subject will receive a brief medical screening. The subject will then have a set of measurements taken using the Core Procedure, will eat a meal of known fat composition, and then undergo a second set of Core measurements. The meals will vary with each experiment and will include low fat; high fat, low polyunsaturated fat; high fat, high polyunsaturated fat; etc.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Nicotine gum; cream pudding prepared by a nutritionist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include the discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste. Subjects are also informed that while the use of blood pressure cuffs to block blood supply to the arm has been shown to be safe for up to 30 minutes and that the repeated blocking of the blood supply for much shorter periods might conceivable pose some unanticipated risks. Nicotine gum may cause a burning or tingling sensation in the mouth, nausea, raised blood pressure, heartburn, and headache.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/09/01
IRB approval number: 2001-10-71
Explanation of IRB approval:
This protocol expired in October 2001 and the investigators subsequently decided not to renew.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California at San Francisco
Most recent approval: 08/02/01
IRB approval number: H5637-15422-04
Explanation of additional approval:
This protocol expired in August 2001 and the investigators subsequently decided not to renew it.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: PET Transmission Studies
OBJECTIVE
The goal of this project is to produce better quality positron emission tomography (PET) images with higher resolution. The researchers will examine how PET technology and analysis algorithms can compensate for the slight movements made by the chest during normal breathing. Subjects will receive no direct benefit, but society may benefit from improved PET diagnostic techniques.
METHODOLOGY
Subjects will receive a single PET scan of 1 to 2 hours without catheterization or radiotracer.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: the discomfort of lying still for a prolonged period; radiation (equivalent to less than 1/20th of a back x-ray). Note that no radiotracer is given.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that research records are not immune to subpoena.
IN 1998, THE PERFORMANCE SITE OF THESE STUDIES CHANGED TO THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/05/02
IRB approval number: 2002-4-70
Explanation of IRB approval:
This protocol was discontinued in April 2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Vascular Reactivity in Alzheimer's Disease via Iontophoresis of Vasoactive Compounds
OBJECTIVES
The goal of this study is to continue to examine the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consenting process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
Subjects will fast for 12 hours prior to their study. On the day of the study, subjects will be screened for factors such as the use of aspirin. A small sample of venous blood will be drawn for lipoprotein analysis in order to correlate low density lipoprotein (LDL) levels, reactivity, and subject illness. A picture of the blood vessels in the hand will be taken using a laser scanner. The laser is similar in intensity to a laser pointer and is not damaging to the skin.
Areas of the skin will be cleaned using isopropyl alcohol. Small amounts of up to five vasodilators and/or constrictors will be dabbed onto the subject's skin. A one-inch square electrode will be placed over the applied chemical, and a tiny electric current applied to cause the chemical to move into localized areas the skin and underlying capillaries. Changes in the circulation will then be non-invasively measured using the same non-invasive laser scanner described above.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
The vasodilators and/or constrictors which may be applied to localized areas of the skin of the arm are: sildenafil citrate, nitro-L-arginine methy ester, nitroprusside, methacholine, and acetylcholine. None of the applications will result in a significant or even measurable systemic dose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness); minor skin irritation or allergic reaction from the chemicals applied to the skin; and a slight, transient tingling feeling from the iontophoresis electrode.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
NOTE: The number of subjects participating under this protocol is reported under "Alzheimer's Disease as a Systemic Disorder" (LBNL-84-001-H03). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
This protocol was discontinued in April of 2003.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/28/03
IRB approval number: 2003-1-43
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of a New Instrument for the Assessment of Vascular Function
OBJECTIVES
The purpose of this study is to compare how well two different devices measure blood flow in the arteries of the arm. The goal is to produce a small, low-cost device that could be used as part of a routine medical check-up to evaluate arterial health.
METHODOLOGY
Up to 30 male and female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Each subject will be examined with both the relaxoscope (Device A, the test device) and B-mode/M-mode procedure (Device B, the current standard).
On the day of the study, each subject will receive a brief medical screening. The first 15 subjects will be tested with Device B first, and the second 15 with Device A first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for four to six minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. Electrocardiogram (EKG) electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about four minutes. Variation of the arterial diameter will be measured before, during, and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Device A -- Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B -- Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/28/03
IRB approval number: 2003-1-42
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: The Study of Breast Cancer Using C-11 Choline and Positron Emission Tomography
OBJECTIVES
To evaluate the biokinetics of C-11 choline with a view towards its usefulness as a radiotracer for the identification of breast cancer by positron emission tomography (PET). Choline is expected to be preferentially picked up by the tumor because of a known increase in choline kinase in malignant cells as compared to normal tissue.
METHODOLOGY
Up to 30 subjects with breast cancer confirmed through other diagnostic procedures will be recruited through contact with primary care physicians. Results from this scan will be correlated with other imaging modalities (magnetic resonance imaging, ultrasound, etc.) that are given to subjects as part of their clinical care. Prior to the scan, a short medical history of the current disease and an accounting of food consumption during the prior 48 hours will be taken.
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to twelve months following the initial scan to evaluate changes in biokinetics associated with the subject's status and to determine if the kinetics of tumor uptake corresponds to that expected from other measures of cancer progression or regression.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Carbon-11 Choline. This is a Radioactive Drug Research Committee monitored protocol.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/10/03
IRB approval number: 2003-1-41
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: The Study of Prostate Cancer Using C-11 Choline and Positron Emission Tomography
OBJECTIVES
To evaluate the biokinetics of Carbon-11 choline with a view towards its usefulness as a radiotracer for the identification of prostate cancer and its metastasis in positron emission tomography (PET). Choline is expected to be preferentially picked up by the tumor because of a known increase in choline kinase in malignant cells as compared to normal tissue. Choline may also be a better candidate for prostate imaging as it is not expected to collect in the bladder.
METHODOLOGY
Up to 30 subjects with prostate cancer confirmed through other diagnostic procedures will be recruited through contact with primary care physicians. Results from this scan will be correlated with other imaging modalities (magnetic resonance imaging, ultrasound, etc.) that are given to the subject as part of their clinical care. Prior to the scan, a short medical history of the current disease and an accounting of food consumption during the prior 48 hours will be taken.
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to twelve months following the initial scan to evaluate changes in biokinetics associated with the subject's status and to determine if the kinetics of tumor uptake corresponds to that expected from other measures of cancer progression or regression.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Carbon-11 Choline. This is a Radioactive Drug Research Committee monitored protocol.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/20/02
IRB approval number: 2002-4-83
Explanation of IRB approval:
Renewal on this protocol is still pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/20/02 to 09/30/02
Explanation:
Initial period of approval falling within fiscal year.
Type(s) of Human Subjects Involvement:
TITLE: Assessment of the Effect of Meal Composition on Vascular Function
OBJECTIVES
The purpose of this research is to study the effects of dietary fat on the short-term function of blood vessels. The researchers will also be testing a new device that measures these effects.
METHODOLOGY
Up to 30 male and female subjects between 21 and 48 years of age will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Subjects will be asked to participate on five separate occasions.
Subjects will be asked to abstain from use of anti-inflammatory drugs for two days before each experiment and to fast and abstain from the use of products known to affect circulation (i.e., cigarettes, weight-loss medications) for 12 hours. On the day of the experiment, each subject will receive a brief medical screening. Each experiment will consist of a baseline blood sample, a set of baseline readings using both Device A and Device B, followed by consumption of a meal of known fat content, and then a second set of measurements and a second blood sample. The fat and carbohydrate content of the meal will vary for each experiment.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 4 to 6 minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. Electrocardiogram (EKG) electrodes will be attached to the hands and right foot. A blood pressure cuff will be applied to the forearm of the subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about four minutes. Variation of the arterial diameter will be measured before, during, and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Cream pudding prepared by a nutritionist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: Those common to venipuncture including bruising and slight risk of infection. Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
Device A -- Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B -- Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena and are subject to review by the Food and Drug Administration.
"Studies of Lipoproteins and Lipid Protein Interactions"
Principal Investigator: Dr. Edward Rubin, Lawrence Berkeley National Laboratory
Project started in: 1977
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/17/03
IRB approval number: 2003-4-65
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
Interdisciplinary training program in cellular, molecular, and biophysical aspects of lipid and lipoprotein metabolism and the process of atherogenesis.
METHODOLOGY
Trainees participate in research carried out under other approved protocols. In the past, trainees have utilized blood samples drawn under the protocol LBNL-79-106-H02 (Krauss, Ronald: "Metabolic & Genetic Origins of Lipoprotein Subclasses"). No other involvement with human subjects has been reported.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human subjects involvement in the last few years has been limited to the use of surplus blood collected for another project. No additional risks to subjects are incurred as a result of this grant.
CONFIDENTIALITY
Confidentiality provisions are the same as those of the source protocol. Only samples collected under consent processes that inform subjects that their samples may be used in other research projects may be used by fellows under this training grant.
NO POST-DOCTORAL TRAINEES PARTICIPATED IN HUMAN SUBJECTS RESEARCH IN FISCAL YEAR 2003.
"Lipoproteins and Atherogenesis in Transgenic Animals"
Principal Investigator: Dr. Ronald M. Krauss, Lawrence Berkeley National Laboratory
Project started in: 1979
This project ended in fiscal year 2003.
Funding for Human Subjects Research: No Funding Sources Reported
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/08/02
IRB approval number: 2002-2-64
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Family Studies
OBJECTIVES
The objective of this study is to examine the inheritance of lipid and lipoprotein levels and the physical properties, as well as chemical composition, of human plasma proteins in order to obtain insights on how to control heart disease.
METHODOLOGY
Up to 80 cc of blood are drawn from subjects via venipuncture. Additionally, a medical interview is conducted with each subject in which demographic information, family/personal health history, dietary, exercise and smoking habits, etc., are requested.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
The risks are those common to venipuncture (bruising, slight risk of infection). Please note that the figure given for Number of Human Subjects, is the number of samples collected; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/23/02
IRB approval number: 2002-2-53
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Transgenic Studies
OBJECTIVES
The objective of this study is to produce mice that carry specific human transgenes. This will enable researchers to study the phenotypic effects of specific genes in an animal model.
METHODOLOGY
Subjects will be recruited from the "Blood Donations for Family Studies" protocol (MM2337). Up to 80 cc of blood is drawn via venipuncture. Additionally, a medical interview is conducted with each subject in which demographic information, family/personal health history, dietary, exercise and smoking habits, etc., are requested. DNA will be obtained for the white blood cells and used as a source of transgenes.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
The risks are those common to venipuncture (bruising, slight risk of infection). Subjects are also informed that there is no plan for them to share in any income arising from the new transgenic mouse strains.
CONFIDENTIALITY
Collection of samples is not anonymous, but samples are supplied to the transgenic facility anonymously. The identity of the human gene donors will not be linked to the resultant mouse strains.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/08/02
IRB approval number: 2002-2-65
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Lipoprotein Research
OBJECTIVES
The objective of this study is to obtain blood for isolation of lipoproteins and plasma proteins, and as a source of lipids for lipoprotein interaction studies. Since certain lipoproteins have been indicated as predisposing individuals to arteriosclerosis and heart disease, this study aims to obtain insights on how to control such diseases.
METHODOLOGY
Not more than a unit of blood (500 cc) will be drawn from donors by venipuncture. Blood bank criteria will be used in determining the frequency of donor use. Some donors may be asked to fast overnight prior to blood withdrawal.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Risks are those common to venipuncture (bruising, mild risk of infection). Please note that the figure given for Number of Human Subjects, is the number of samples collected; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
This study has been discontinued.
"Characterization of Human Mammary Cells"
Principal Investigator: Dr. Martha R. Stampfer, Lawrence Berkeley National Laboratory
Project started in: 1979
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/13/03
IRB approval number: 2003-1-45
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This research is concerned with the growth control of human breast cells and the relationship of differentiation with transformation.
Human milk contains a small number of living cells that have been sloughed off from the breast tissue during the secretory process. These sloughed cells are isolated from human milk samples and studied to gain an insight into the events taking place within the breast tissue.
Subjects are asked to provide information relating to their general health, age, race, and birth of their child. They express one or more samples of breast milk using their own equipment in the privacy of their home. As subjects are performing this process on a regular basis, no risk directly related to the research is anticipated.
These samples are not collected anonymously. However, when tissue samples or cell cultures are made available to other researchers they are identified only by code number. Subjects are informed as part of the consent process that their samples may be used by others.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/13/03
IRB approval number: 2003-1-45
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The investigator's goal is to determine the morphological, biological, and biochemical properties associated with normal, atypical, and malignant mammary epithelial cells. Such studies will elucidate mechanisms of human carcinogenesis and aid clinicians in the early detection of breast cancer.
The research will use portions of residual tissues from medical procedures such as aspiration of cysts, mammary biopsies, reduction mammoplasty, or mastectomy. Residual tissues from other sites (e.g., skin, cervix) may also be obtained. Samples are identified by patient number and donor location and may be accompanied by medical history data.
Collection of the samples poses no additional risk to the subject. Samples are only obtained from subjects who have given permission for the research use of their tissues. These samples are not collected anonymously, but arrive at the laboratory already identified by code number.
"Myocardial Flow, Function, and Metabolism by PET & MRI"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1980
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 4
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/28/03
IRB approval number: 2003-1-43
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of New Instrument for the Assessment of Vascular Function
OBJECTIVES
The purpose of this study is to compare how well two different devices measure blood flow in the arteries of the arm. The goal is to produce a small, low-cost device that could be used as part of a routine medical check-up to evaluate arterial health.
METHODOLOGY
Up to 30 male and female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Each subject will be examined with both the relaxoscope (Device A, the test device) and B-mode/M-mode procedure (Device B, the current standard).
On the day of the study, each subject will receive a brief medical screening. The first 15 subjects will be tested with Device B first, and the second 15 with Device A first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 5 to 6 minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. Electrocardiogram (EKG) electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about five minutes. Variation of the arterial diameter will be measured before, during and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
A subset of the subjects will have nitroglycerin or Albuterol administered to stimulate brachial artery dilation. The IRB approved this modification in September 2003.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Device A -- Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B -- Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena, and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
NOTE: The number of subjects participating under this protocol is reported under "Experimental Medicine Clinical" (LBNL 75-001-H02). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/17/01
IRB approval number: 2001-10-72
Explanation of IRB approval:
This protocol was discontinued in December 2002.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California at San Francisco
Most recent approval: 08/23/01
IRB approval number: H5637-15423-04
Explanation of additional approval:
This protocol expired in August of 2001 at UCSF and the investigators have opted not to renew it.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 10/01/02 to 12/12/02
Explanation:
This protocol was discontinued on December 12, 2002.
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of the Benefits of Motion Compensation in Cardiac Positron Emission Tomography (PET) with Respiratory and Cardiac Gating
OBJECTIVES
The small movements of the chest caused by breathing and the beating of the heart currently degrades the quality of positron emission tomography (PET) images. The purpose of this project is to evaluate the utility of motion compensation in cardiac PET studies. The individual subjects will be healthy volunteers and will not benefit from the research. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Up to 20 healthy human volunteers will be sought through advertisement. Subjects will receive a standard PET scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First a transmission scan without radiotracer is performed to allow corrections of the emission data. Subjects will then receive one injection of 18F-fluorodeoxyglucose (FDG). Subjects may not move during the scans. The total procedure should take two to two-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
18F-fluorodeoxyglucose (FDG)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray). There is no increase in risk associated with use of the rubber bellows.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These PET studies are carried out at the University of California, San Francisco.
This protocol was discontinued in December 2002.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/22/02
IRB approval number: 2002-10-61
Explanation of IRB approval:
This protocol was discontinued in March 2003.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California, San Francisco
Most recent approval: 08/14/02
IRB approval number: H5619-18931-01
Explanation of additional approval:
Full approval by UCSF is a condition of approval from the LBNL IRB and must therefore precede the LBNL approval date.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 10/01/02 to 03/12/03
Explanation:
This protocol was discontinued in March 2003.
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Dynamic ECT Algorithms for Inconsistent Projection Data
OBJECTIVES
The purpose of this project is to test mathematical algorithms for the analysis of data produced by single photon emission computed tomography (SPECT) studies. The individual subjects will be heart patients who have been prescribed a cardiac SPECT scan by their personal physicians. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Up to five healthy human volunteers will be sought through advertisement. Subjects will receive a standard SPECT scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First, the subject is given a chest x-ray to allow corrections of the emission data. Subjects will then receive one injection of thallium-201. Subjects may not move during the scans. The total procedure should take one to one-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
Thallium-201
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
SPECT scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These SPECT studies are carried out at the University of California, San Francisco.
This protocol was discontinued in March 2003.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/23/02
IRB approval number: 2002-10-14
Explanation of IRB approval:
Researchers are currently considering whether or not to discontinue this protocol.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California San Francisco
Most recent approval: 08/22/02
IRB approval number: H260-15408-05
Explanation of additional approval:
Researchers are currently deciding whether to continue or discontinue this protocol.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: List Mode Data Acquisition for Clinical PET Studies and Retrospective Gating of Cardiac and Respiratory Motion
OBJECTIVES
The small movements of the chest caused by breathing and the beating of the heart currently degrade the quality of positron emission tomography (PET) images. The purpose of this project is to evaluate the utility of motion compensation in PET studies. The individual subjects will be heart patients who have been prescribed a cardiac PET scan by their personal physicians. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Subjects will receive a standard PET scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First a transmission scan without radiotracer is performed to allow corrections of the emission data. Subjects will then receive one injection of 18F-fluorodeoxyglucose (FDG). Subjects may not move during the scans. The total procedure should take two to two-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
18F-fluorodeoxyglucose (FDG)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray). There is no increase in risk associated with use of the rubber bellows.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These PET studies are carried out at the University of California, San Francisco.
"Alzheimer's Disease as a Systemic Disorder"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1984
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Identifier or number: RMP 66
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/05/02
IRB approval number: 2002-4-70
Explanation of IRB approval:
Researchers were uncertain whether or not to discontinue this protocol in April 2003. It was finally discontinued in October 2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Vascular Reactivity in Alzheimer's Disease via Iontophoresis of Vasoactive Compounds
OBJECTIVES
The goal of this study is to continue to examine the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
Subjects will fast for 12 hours prior to their study. On the day of the study, subjects will be screened for factors such as the use of aspirin. A small sample of venous blood will be drawn for lipoprotein analysis in order to correlate low density lipoprotein (LDL) levels, reactivity and subject illness. A picture of the blood vessels in the hand will be taken using a laser scanner. The laser is similar in intensity to a laser pointer and is not damaging to the skin.
Areas of the skin will be cleaned using isopropyl alcohol. Small amounts of up to five vasodilators and/or constrictors will be dabbed onto the subject's skin. A one inch square electrode will be placed over the applied chemical, and a tiny electric current applied to cause the chemical to move into localized areas the skin and underlying capillaries. Changes in the circulation will then be non-invasively measured using the same non-invasive laser scanner described above.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
The vasodilators and/or constrictors which may be applied to localized areas of the skin of the arm are sildenafil citrate, nitro-L-arginine methy ester, nitroprusside, methacholine, and acetylcholine. None of the applications will result in a significant or even measurable systemic dose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness); minor skin irritation or allergic reaction from the chemicals applied to the skin; a slight, transient tingling feeling from the iontophoresis electrode.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
This protocol was discontinued in October 2003.
"National Runners and Walkers Health Study"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1991
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 3
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 05/07/03
IRB approval number: 2003-1-46
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 161242
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The objective of this study is to collect self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), running activity, and smoking history.
The study hopes to achieve this goal by surveying active exercisers. Questionnaires are distributed to the readers of 'Runner's World' magazine and to participants in current long-distance running events; additional questionnaires were sent to the subscribers of 'Walking' magazine. In total 491,667 questionnaires were mailed in calendar year 2001. Subjects may also be recruited by word of mouth.
The investigator does not contact individuals who do not return an initial survey and consent statement. The survey asks questions about exercise level, diet, weight, and personal habits. Subjects are also asked to sign a release for access to their medical records. If the release is signed, the investigator sends a separate request to the physician's office where the relevant information is abstracted by the physician or his staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.
The subject's participation is limited to completing the survey and allowing access to existing medical records. The only risk to the subject is potential loss of some personal privacy. Results are not collected anonymously and subjects are asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results, which do not identify individual participants, are published.
OVER 160,000 SUBJECTS HAVE ENROLLED IN THE STUDY THROUGH NOVEMBER 2002.
"Genes Affecting Metabolic Responses to Dietary Fat and Carbohydrates (Formerly, Genetic and Metabolic Factors Affecting Response of Lp(a) to Dietary Fat)"
Principal Investigator: Dr. Ronald M. Krauss, Lawrence Berkeley National Laboratory
Project started in: 1992
Funding for Human Subjects Research: No Funding Sources Reported
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 4
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/23/02
IRB approval number: 2002-2-31
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
TITLE: Positional Cloning of the ATHS Gene on Chromosome 19p
OBJECTIVES
The objective of this study is to pursue identification of a gene or gene(s) and any mutations that create a susceptibility to atherosclerosis, the ATHS gene. The researchers will also be seeking to identify changes in the gene that cause the atherogenic-lipoprotein phenotype (ALP) which is prevalent in families with heart disease.
METHODOLOGY
Fifty to seventy-five nuclear families, some previously enrolled in other Krauss studies, will be recruited. Blood tests and surveys will be used initially to characterize the phenotypes of subject families. Some of the subjects may be minors.
LBNL involvement is limited to analysis of serum samples and surveys from the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
LBNL involvement is limited to the analysis of survey data and blood samples collected at another site. No additional risk to subjects is incurred by LBNL analysis of samples. Please note that the figure given for Number of Human Subjects, is the number of samples forwarded to Berkeley Lab for analysis; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/30/02
IRB approval number: 2002-9-71
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Effects of Altered Dietary Macronutrient Composition and Weight Loss on Metabolic and Genetic Features of Atherogenic Lipoprotein Phenotype
OBJECTIVES
The objective of this study is to investigate the role of diet and genetic factors on lipoproteins in mildly overweight men that are at least 20 years old. Subjects will be placed on diets with different amounts and types of fats, protein, and carbohydrate, and their responses to the diet measured by various means.
METHODOLOGY
Subjects will initially be screened for cholesterol, lipids, blood sugar, body fat, blood pressure, and medical history. Blood samples will be drawn for analysis of plasma lipids and lipoproteins. Enrolled subjects will be retested before and after one week of following an American Heart Association recommended diet plan. Subjects will then be randomly assigned to one of four test diets (current guidelines, moderate fat/carbohydrate, high dairy fat/low carbohydrate, low dairy fat/low carbohydrate) and follow it for twelve weeks. Fat biopsies, blood samples, diet record check, and a mini-physical will be conducted at week 0, 3, 8, and 12. Subjects will also be contacted at 6, 12, 18, and 24 months post-participation and asked about their diet, lifestyle, weight, blood pressure, and lipid profiles.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
LBNL involvement is limited to the analysis of survey data and tissue samples collected at another site. No additional risk to subjects is incurred by LBNL analysis of samples. Please note that the figure given for Number of Human Subjects reflects the number of subjects enrolled in the study.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that their data may be viewed by the Children's Hospital Oakland Research Institute (CHORI) funding agency, Dairy Management, Inc.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 11/13/01
IRB approval number: 2001-11-81
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Genetic and Metabolic Factors Affecting Response of Lp(a) to Dietary Fat
OBJECTIVES
The objective of this study is to investigate the role of genetic factors in influencing lipoprotein responses to varying dietary fat intake and to assess the ultimate effects of such gene-diet interactions on atherosclerosis. Blood tests and surveys are used initially to characterize subjects and their families; individuals meeting certain criteria may be invited to participate in experimental protocols. Some of the subjects may be minors.
METHODOLOGY
LBNL involvement is limited to analysis of serum samples and surveys from the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
LBNL involvement is limited to the analysis of survey data and serum samples collected at another site. No additional risk to subjects is incurred by LBNL analysis of samples. Please note that the figure given for Number of Human Subjects is the number of samples forwarded to Berkeley Lab for analysis; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/16/01
IRB approval number: 2001-6-150
Explanation of IRB approval:
Protocol was discontinued in May 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 06/16/01 to 05/22/02
Explanation:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Type(s) of Human Subjects Involvement:
TITLE: Effects of High- and Low-Fat Diets on Body Weight and Lipoprotein Subfractions in Monozygotic Twins
OBJECTIVES
The objective of this study is to investigate the role of genetic factors in influencing lipoprotein responses to varying dietary fat intake and to assess the ultimate effects of such gene-diet interactions on atherosclerosis. The specific aim of this subproject is to test different diet schemes in 50 pairs of identical male twins that are discordant for exercise.
METHODOLOGY
LBNL involvement is limited to analysis of serum samples and surveys from the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
LBNL involvement is limited to the analysis of survey data and serum samples collected at another site. No additional risk to subjects is incurred by LBNL analysis of samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators.
THIS PROTOCOL WAS DISCONTINUED IN MAY 2002.
"Gene Specific Responses to Exercise in Discordant Twins (Formerly, "Effects of Running on HDL and LDL Subclasses of MZ Twins")"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1992
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 4
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/22/03
IRB approval number: 2003-8-83
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 70
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This study has two specific aims: to estimate the effects of high level exercise and reduced adiposity on blood lipoprotein apolipoproteins and circulating triglyceride levels and to test whether the effects of adiposity and exercise on lipoprotein concentrations are genotype dependent.
The study utilizes a national survey ("The National Runners Health Study," LBNL-91-107-H01) to identify identical twins with discordant cardiovascular activity levels. The researcher has developed a population of such twins who are willing to participate in the study. Participation consists of completing an additional questionnaire and having blood drawn when the volunteer enters the study and again after two years as a follow-up. Serum samples are obtained by routine venipuncture through either the subject's own physician or through a local lipoprotein screening program. The risks are those common to clinical venipuncture (bruising and the slight chance of infection).
Results are not collected anonymously, and twins will know that their sibling is enrolled in the study. Subjects are also asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results that do not identify individual participants are published.
The same 35 twin pairs have been studied for the last several years. The researcher has a new source of funding and is seeking to increase his subject population to 200 male and 200 female twin pairs.
"Modulation of Oxidant Stress-Mediated Atherosclerosis"
Principal Investigator: Dr. Diane L. Tribble, Lawrence Berkeley National Laboratory
Project started in: 1994
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: MM6672
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/23/02
IRB approval number: 2002-2-54
Explanation of IRB approval:
Dr. Tribble has left LBNL and this protocol has been discontinued. No human subjects material was studied in fiscal year 2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
The objective of this study is to evaluate plasma and isolated lipoproteins for antioxidant and hydroperoxide concentrations. This information is fundamental to understanding differences in the atherogenicity of lipoprotein subclasses.
METHODOLOGY
Blood collected under another protocol (see below) is used as the source for the isolated erythrocytes and hemoglobin which are analyzed.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human involvement in this study is limited to the analysis of blood collected under another project, "Lipoproteins and Atherogenesis in Transgenic Animals", LBNL-79-106-H02 (R. Krauss, principal investigator). The number of human subjects indicated above is the number of samples received.
CONFIDENTIALITY
While subjects are not anonymous under the source protocol, samples passed to this researcher are not identified.
This protocol has been discontinued.
"Genetic Testing for Evaluation of Heart Disease Risk"
Principal Investigator: Dr. Ronald M. Krauss, Lawrence Berkeley National Laboratory
Project started in: 1998
This project ended in fiscal year 2003.
Funding for Human Subjects Research: No Funding Sources Reported
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/12/01
IRB approval number: 2001-10-74
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 10/12/01 to 08/09/02
Explanation:
Period between last IRB review and withdrawal of the protocol by the investigator.
Type(s) of Human Subjects Involvement:
TITLE: "Reconsent of Research Subjects"
OBJECTIVES
The objective of this study is to develop and evaluate DNA-based testing for common genetic traits affecting heart disease risk.
METHODOLOGY
Blood collected under another protocol (see below) is used as the source for DNA.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human involvement in this study is limited to the analysis of blood collected under another protocol, "Lipoproteins and Atherogenesis in Transgenic Animals", LBNL-79-106-H02 (R. Krauss, principal investigator). This protocol is used to re-contact subjects who originally participated in this research before genetic testing for heart disease was contemplated, and to obtain their consent to use archived samples for genetic research.
CONFIDENTIALITY
Collection of the original samples was not anonymous. During the re-consent process subjects are reminded that a portion of the blood was stored for future analysis. Subjects are recontacted under this protocol so they may consent to genetic analysis of DNA derived from their blood sample. Subjects are also informed that their samples and data may be shared anonymously with commercial laboratories developing new genetic tests.
THIS PROTOCOL WAS DISCONTINUED IN AUGUST 2002.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/20/02
IRB approval number: 2002-2-65
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Lipoprotein Research
OBJECTIVES
The objective of this study is to obtain blood for isolation of lipoproteins and plasma proteins, as a source of lipids for lipoprotein interaction studies, and as a source of DNA for genetic research. Since certain lipoproteins have been indicated as predisposing individuals to arteriosclerosis and heart disease, this study aims to obtain insights on how to control such diseases.
METHODOLOGY
Not more than a unit of blood (500 cc) will be drawn from donors by venipuncture. Blood bank criteria will be used in determining the frequency of donor use. Some donors may be asked to fast overnight prior to blood withdrawal.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Risks are those common to venipuncture (bruising, mild risk of infection). Please note that the number of subjects participating under this protocol is reported on under project LBNL-79-106-H02 (Dr. R Krauss); no additional samples are collected to meet the goals of this project.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators and that genetic analysis may be performed on DNA derived from the blood.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 11/13/01
IRB approval number: 2001-11-81
Explanation of IRB approval:
Dr. Krauss moved to a different institution in the spring of 2002. No subjects were seen under his LBNL protocols since their last renewals. No funds were expended.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Genetic and Metabolic Factors Affecting Response to Dietary Fat
OBJECTIVES
The objective of this study is to investigate the role of genetic factors in influencing lipoprotein responses to varying dietary fat intake and to assess the ultimate effects of such gene-diet interactions on atherosclerosis. Blood tests and surveys are used initially to characterize subjects and their families; individuals meeting certain criteria may be invited to participate in experimental protocols. Some of the subjects may be minors.
METHODOLOGY
LBNL involvement is limited to analysis of serum samples and surveys from the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Risks are those common to venipuncture (bruising, mild risk of infection). Please note that the number of subjects participating under this protocol is reported on under project LBNL-92-106-H04, Subprotocol MM 4632 (Dr. R Krauss); no additional samples are collected to meet the goals of this project.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
This study has been discontinued.
"National Health Survey on the Internet"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 5
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/21/03
IRB approval number: 2003-1-47
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVE
The objective of this study is to collect self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), vigorous exercise, and general health history (e.g., smoking, alcohol consumption).
METHODOLOGY
The researchers have posted an extensive questionnaire on health and life style on the internet. The survey is completed on line, and future follow-ups will also be distributed electronically. An extensive series of interactive features such as construction of a personal food consumption 'pyramid' are available without enrolling in the study. In order for the survey to be forwarded to the researcher's web site, potential subjects must give their age and ask to enroll, complete the entire survey, and respond affirmatively to a second consent statement after completing the study.
The survey asks questions about exercise type and level, diet, weight, health history, and personal habits. Subjects are also asked to print out and sign a release for access to their medical records. If the release is signed, the investigator sends a separate request to the physician's office where the relevant information is abstracted by the physician or the staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.
RISKS/PRIVACY/CONFIDENTIALITY
Minors are excluded from participation in the study. The subject's participation is limited to completing the survey and allowing access to existing medical records. The only risk to the subject is potential loss of some personal privacy. Results are not collected anonymously and subjects are asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results that do not identify individual participants are published.
OVER 12,000 SUBJECTS HAVE ENROLLED IN THIS STUDY SINCE ITS INITIATION.
During the 2001 to 2002 approval period, there were production problems with the website and no new visitors were enrolled.
"Breast Cancer Specific PET Instrumentation"
Principal Investigator: Dr. William W. Moses, Lawrence Berkeley National Laboratory
Project started in: 1998
Funding for Human Subjects Research: