Pharmacogenetics of Hypertriglyceridemia in Hispanics

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanley Korenman, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00086437
First received: July 1, 2004
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

To study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.


Condition
Cardiovascular Diseases
Heart Diseases
Hypertriglyceridemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pharmacogenetics of Hypertriglyceridemia in Hispanics

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Plasma triglycerides [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 274
Study Start Date: July 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Increased serum triglycerides are a significant independent risk factor for coronary artery disease and myocardial infarction. Besides typical lifestyle modification, the treatment with fibrates is standard in patients with hypertriglyceridemia. There is ample evidence that genetic factors influence triglyceride levels. Identifying genes, which affect triglyceride levels and moreover determining the response to fibrates is of great interest. Hispanics are among the populations with the highest prevalence of this disease. Therefore focusing on a high-risk population further adds to the overall significance of this study. Identifying genes and genetic mechanisms contributing to the treatment response can lead to new or improved treatment methods.

DESIGN NARRATIVE:

The study tests the hypothesis that differences in therapeutic effects of fibrates are related to variations in networks of genes regulating lipoprotein metabolism. An efficient approach for identifying and categorizing major gene variants is based on determination of sequence haplotypes. Only Hispanics will be studied to provide a homogenous population for this genetic study. Furthermore, Hispanics are the fastest growing ethnic group in the U.S. and have a higher prevalence of hypertriglyceridemia than other ethnic groups. The investigators will measure plasma triglycerides (TG), other lipids and lipoproteins, and lipoprotein particle size before and after treatment with fenofibrate in 800 Hispanic individuals with hypertriglyceridemia. They will reconstruct the haplotypes of 16 candidate genes known to regulate TG metabolism and mediate the effect of fibrates. The associations between phenotypes and major haplotypes will be analyzed in a two stage design, with the first half of the sample serving a hypothesis-generating function. Those candidate gene haplotypes that are found to be associated with quantitative traits and drug responses in the first half of the sample will then be tested for confirmation in the second half. In addition, data from the full cohort will be analyzed to identify additional pharmacogenetic associations that may require greater statistical power. Finally, direct fine mapping will be performed in the four most promising genes to identify the responsible variations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hispanics with hypertriglyceridemia

Criteria

Hispanics with hypertriglyceridemia

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00086437

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Stanley Korenman, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Stanley Korenman, Assoc Dean Ethics, Prof Endocrinology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00086437     History of Changes
Other Study ID Numbers: 1260, R01HL076771
Study First Received: July 1, 2004
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 14, 2014