Viewing Study NCT00083369



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00083369
Status: COMPLETED
Last Update Posted: 2013-11-19
First Post: 2004-05-21

Brief Title: Genetic and Environmental Determinants of Triglycerides GOLDN
Sponsor: University of Alabama at Birmingham
Organization: University of Alabama at Birmingham

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2013-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 treatment
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 small lactate dehydrogenase LDL particles are particularly atherogenic There is considerable variation in the response of TGs and related phenotypes to the environment

The study is in response to a Request for Applications RFA entitled Interaction of Genes and Environment in Shaping Risk Factors for Heart Lung Blood and Sleep Disorders The RFA was released in October 2001

DESIGN NARRATIVE

Measurements will be collected before and after a dietary fat challenge to assess postprandial TGs and related atherogenic phenotypes VLDL TGs chylomicron TGs TG remnant particles high-density lipoproteinHDL and low density lipids LDL particle sizes total cholesterol LDL-C and HDL-C In families with 2 or more members in a sibship with high TGs 130 mgdl the authors will conduct a short-term placebo-controlled randomized trial of fenofibrate in all willing and eligible family members anticipated sample size 1200 A two-period crossover design will be executed with a 2-week washout between two 3-week treatment periods placebo or micronized fenofibrate 160 mg About 1000 family members have a Marshfield genome marker set available as part of national Heart Lung and Blood NHLBI FHS the remaining 1400 will be typed using the same marker set They will conduct genome-wide linkage analyses using state-of-the-art methods to localize novel genetic loci contributing to TG response in the context of fat loading and fenofibrate treatment They will type 15 single nucleotide polymorphisms SNPs in ten candidate genes known to contribute to the response of TGs to dietary fat and fenofibrate and create haplotypes for association studies They will use combinatorial partitioning methods and neural networks to test association of the individual SNPs and haplotypes with response to the two environmental interventions The identification of genetic loci that predict TG response in the presence of two disparate contexts fat loading and fibrate therapy may provide insights into genetic pathways a predisposing to hypertriglyceridemia ultimately leading to avenues for primary prevention and b predicting response to TG lowering leading to new drug targets for hypertriglyceridemia

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U01HL072524-05 NIH None httpsreporternihgovquickSearchU01HL072524-05