USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-92-106-H01

Project Title:

Effect of Gemfibrozil on LDL and HDL Subclass Distribution, Postprandial Lipemia, and Lipoprotein Composition (see LBL-93-8-117 in 1994 database)

Principle Investigator: Dr. Ronald M. Krauss

Project started in: 1992

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: Sequoia Hospital District

Amount: $110,000 (Est.)

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: February 17, 1995
IRB Approval Number: 95-2-101

Number of Human Subjects in the Last Reporting Period for this Project: 219
(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.

(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])

OBJECTIVES

To assess the effectiveness of gemfibrozil on blood cholesterol and triglycerides and determine if it is effective in reducing specific subclasses of low density lipoprotein (LDL) and/or increasing specific subclasses of high density lipoprotein (HDL) in high risk lipoprotein patterns in subjects with mild triglyceride elevation and low levels of high-density lipoprotein levels. In a second phase of the study, the efficacy of gemfibrozil and niacin in combination is tested on the atherogenic lipoprotein distribution in patients with combined hyperlipidemia. Both phases hope to contribute to the development of better treatment for elevated cholesterol.

METHODOLOGY

Blood samples (for LBNL analysis) were drawn at another site, where the study was conducted. For each subject, twelve samples are analyzed over the course of thirty weeks of the study. The samples are studied with the use of gel electrophoresis.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

LBNL involvement is limited to analysis of blood serum samples. No additional risk to subjects is incurred by LBNL analysis of samples.