USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-92-107-H05

Project Title:

Effects of Running on HDL and LDL Subclasses of MZ Twins (see LBL-93-8-121 in 1994 database)

Principle Investigator: Dr. Paul T. Williams

Project started in: 1992

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Explanation:

Unfunded pilot program.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: August 18, 1995
IRB Approval Number: 95-8-130

Number of Human Subjects in the Last Reporting Period for this Project: 42
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

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 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; the slight chance of infection).