Dr. Jon
B.
Klein
University of Louisville
570 South Preston Street
Louisville, KY 40202
Phone: 502-852-5239
Fax: 502-852-4384
E-mail: jon.klein@kdp.louisville.edu
Number of Human Subjects projects reported: 2
| ULRF-05-HSC # 168.05 | "Assessing the Impact of Environmental Exposures and Inhaled Corticosteroid Treatment on the Urinary Proteome in Children with and without Asthma" |
| ULRF-05-Human DM Nephropathy | " The Urinary Proteome and Renal Function Loss in Diabetes" |
"Assessing the Impact of Environmental Exposures and Inhaled Corticosteroid Treatment on the Urinary Proteome in Children with and without Asthma"
Principal Investigator: Dr. Mary Jane Kennedy, University of Louisville Research Foundation
Project started in: 2005
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Louisville Research Foundation
Most recent approval: 03/21/05
IRB approval number: 168.05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 27
Reporting period for number of human subjects:
Fiscal Year 2005
Type(s) of Human Subjects Involvement:
Asthma remains a significant health problem in the pediatric population affecting approximately 7 percent of children less than 18 years of age in the United States. In the Louisville metro area alone, an estimated 13,000 children are affected by this increasingly common condition. Although the precise etiology of asthma remains unknown, it is now recognized that both genetic predisposition and environmental exposure to a number of chemical and/or infectious agents may be operative in the onset, persistence, and exacerbation of the clinical asthma phenotype. The goal of this project is to identify candidate urinary proteins that may serve as predictors of disease onset and treatment compliance in children exposed to environmental toxins and treated with inhaled corticosteroids, respectively. The primary objective of this investigation is to characterize the urinary proteome in children (1) in the Rubbertown industrial area of West Louisville and (2) prior to and during treatment with inhaled corticosteroid therapy. The central hypothesis of this proposal is that the urinary protein expression pattern differs as a function of environment and inhaled corticosteroid treatment.
"The Urinary Proteome and Renal Function Loss in Diabetes"
Principal Investigator: Dr. Jon B. Klein, University of Louisville Research Foundation
Project started in: 2005
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Louisville Research Foundation
Most recent approval: 12/07/05
IRB approval number: 515.04
Explanation of IRB approval:
Initial approval date was between 10/1/04 and 9/30/05. Protocol revised and re-reviewed. IRB letter states "Human Subjects Protection Program Office. It has been determined by the chair of the Institutional Review Board that the study is exempt according to 45 CFR 46.101(b) 2, since the research involves the collection of data recorded in such a manner that subjects cannot be identified."
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 2005
Type(s) of Human Subjects Involvement:
The risk of End Stage Renal Disease (ESRD) due to diabetes has tripled in recent decades. This epidemic of ESRD is due to a real increase in the proportion of diabetic patients developing renal function loss rather than a consequence of improved survival of these patients. To contain this epidemic, research efforts are urgently needed to identify at an early stage those individuals experiencing renal function loss in diabetes so that new preventive programs can be developed. Particularly lacking is knowledge about the initiation and promotion of the early renal function decline. Recently, we found that renal function begins to decline in a large proportion of patients with Type 1 diabetes once microalbuminuria (MA) develops. This early renal function decline was unrelated to further increases in the level of urinary albumin excretion but was associated with elevated levels of urinary chemokines. We peopose to use high-throughput liquid chromatography-mass spectrometry (LC-MS) approaches to identify urinary biomarkers of diabetic renal disease.