We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Pharmacogenetics of Hypertriglyceridemia in Hispanics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00086437
Recruitment Status : Completed
First Posted : July 5, 2004
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
To study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.

Condition or disease
Cardiovascular Diseases Heart Diseases Hypertriglyceridemia

Detailed Description:


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.


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.

Study Design

Study Type : Observational
Actual Enrollment : 274 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pharmacogenetics of Hypertriglyceridemia in Hispanics
Study Start Date : July 2004
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Plasma triglycerides [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hispanics with hypertriglyceridemia
Hispanics with hypertriglyceridemia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086437

Sponsors and Collaborators
University of California, Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stanley Korenman, MD University of California, Los Angeles
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: July 5, 2004    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

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