USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-93-106-H05

Project Title:

Genetic Determinants of Lipoprotein Changes Induced by Post Menopausal Hormone Replacement (see LBL-93-9-48 in 1994 database)

Principle Investigator: Dr. Ronald M. Krauss

Project started in: 1993

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: $33,400 (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: September 22, 1995
IRB Approval Number: 95-6-119

Number of Human Subjects in the Last Reporting Period for this Project: 16
(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

The objective of this study is to assess the effectiveness of hormone replacement on blood cholesterol and triglycerides to determine if it is effective in reducing specific classes of low density lipoprotein (LDL) and/or increasing specific subclasses of high density lipoprotein (HDL) in post-menopausal women. While it is known that women on estrogen replacement therapy have a reduced risk of atherosclerosis, this research seeks to demonstrate the mechanism by which this risk reduction is achieved by studying the same women both on and off estrogen therapy.

METHODOLOGY

LBNL involvement is limited to analysis of serum samples from the study.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

LBNL involvement is limited to the analysis of serum samples collected at another site. No additional risk to human subjects is incurred by LBNL analysis of samples.