Status:
COMPLETED
Genetic and Environmental Determinants of Triglycerides (GOLDN)
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atherosclerosis
Cardiovascular Diseases
Eligibility:
All Genders
19+ years
Brief Summary
To characterize the genetic basis of the variable response of triglycerides to two environmental contexts, one that raises triglycerides (dietary fat), and one that lowers triglycerides (fenofibrate t...
Detailed Description
BACKGROUND: Hypertriglyceridemia is emerging as an important predictor of atherosclerosis, and recent evidence suggests related phenotypes of triglycerides (TGs), such as TG remnant particles and sma...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥18 years of age
- fasting TGs \<1,500 mg/dl
- willingness to participate in the study and attend the scheduled clinic exams
- member of a family with at least two members in a sibship
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) results within normal range
- creatinine ≤2.0 mg/dl
- Exclusion criteria:
- history of liver, kidney, pancreas, or gall bladder disease or malabsorption
- current pregnancy
- insulin use
- use of lipid-lowering drugs (including prescription, over the counter, and nutriceuticals; volunteers taking these agents were withdrawn from them at least 4 weeks prior to the study with physician's approval)
- use of warfarin
- women of childbearing potential not using an acceptable form of contraception
- known hyper-sensitivity to fenofibrate
- history of pancreatitis within 12 months prior to enrollment
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1327 Patients enrolled
Trial Details
Trial ID
NCT00083369
Start Date
September 1 2002
End Date
May 1 2009
Last Update
November 19 2013
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