Obesity Clinical Trial - Genetics of CVD Risk Factors in Samoans

Status Completed

Clinical Trial Summary

To evaluate the role of known genes involved in lipid metabolism on serum lipid and apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to the biobehavioral changes of modernization.

Clinical Trial Description

BACKGROUND:

Modernizing Samoans are characterized by high levels of certain cardiovascular disease (CVD) risk factors such as extreme adiposity and high prevalences of obesity and hypertension. However, lipid levels in Samoans such as total cholesterol and high density lipoprotein (HDL) cholesterol are not consistent with their obesity and not always consistent with ecological measures of modernization.

DESIGN NARRATIVE:

The cross-sectional study used serum lipid and lipoprotein and dietary data collected in 1994 and 1995 in American and Western Samoa to compare the American and Western Samoans. Quantitative determinations were made of lipid and apolipoprotein levels differences between the two groups. Estimates were made of the effects of dietary intake, body size, and smoking on lipid and apolipoproteins. Cross-sectional analyses were performed on genetic factors influencing lipid and lipoprotein levels. Statistical analyses were conducted to test hypotheses about gene-environment interactions and gene-gene interactions in polynesians from American Samoa and Western Samoa.

Diet, physical activity and body size vary with exposure to the influences of economic modernization and the adoption of non-traditional behaviors. Although adiposity and its central distribution, insulin, blood pressure and dietary cholesterol increase from Western Samoa to American Samoa, saturated fat intakes due to coconuts and cigarette smoking are greater in Western Samoa. Thus, modernization does not produce simple unilineal changes in risk factors. The investigators examined very specific hypotheses, based on the cross-sectional data collected in 1994 and 1995, about the influence of genes on lipids, about genetic interactions on lipids and about concrete environmental and specific gene interactions on lipid outcomes.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00005528
Study type	Observational
Source	National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status	Completed
Phase	N/A
Start date	April 1995
Completion date	February 2000

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.