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Home > "G" Clinical Trials Conditions > Genetic Determinants:Low HDL, High Triglycerides, Obesity  Genetic Determinants:Low HDL, High Triglycerides, Obesity
Genetic Determinants:Low HDL, High Triglycerides, Obesity
For Condition: Atherosclerosis,Cardiovascular Diseases,Obesity,Hypertriglyceridemia,Heart Diseases,Metabolic Syndrome X
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To conduct genetic studies of the metabolic syndrome which is characterized by very low levels of high density lipoprotein cholesterol (HDL-C), hypertriglyceridemia, and obesity.
Details: BACKGROUND: Over the past 10 years, extensive studies have been conducted in Turkey to determine the risk factors for heart disease. Studies involving approximately 10,000 Turkish men and women from six different regions of Turkey have established that this population is unique in several ways. The Turks have the lowest plasma levels of high density lipoprotein cholesterol (HDL-C) of almost any population in the world (75 percent of the men and 50 percent of the women have HDL-C levels <40 mg/dl). The mean HDL-C levels are 10-15 mg/dl lower than those in Western European or American populations. In addition, Turks, especially Turkish women, have a tendency toward obesity [38.8 percent of the women have body mass index (BMI) >30 kg/M2], and both men and women have a tendency toward hypertriglyceridemia. The low HDL-C, however, is independent of obesity or hypertriglyceridemia. Samples from this well-characterized population provide a unique opportunity to explore the genetic determinants associated with the high prevalence of low HDL-C, hypertriglyceridemia, and obesity (characteristics of the metabolic syndrome). The study is in response to a Request for Applications entitled "NHLBI Innovative Research Grant Program" released in July, 2001. The purpose of the initiative is to support new approaches to heart, lung, and blood diseases and sleep disorders that use existing data sets or existing biological specimen collections whether obtained through National Heart, Lung, and Blood Institute support or not. DESIGN NARRATIVE: The study will analyze DNA from frozen blood samples to investigate new candidate gene targets that may provide insights into the abnormalities characterizing this population of Turks. The samples and extensive biodata are available on all 10,000 participants. In Specific Aim 1, the investigators will identify polymorphisms in acyl CoA:diacylglycerol acyltranferase (DGAT)- I and -2 and in ATP-binding cassette A I (ABCA I) genes that are associated with differences in BMI, HDL-C, and triglyceride concentration, and other parameters such as blood pressure. These studies will focus significantly on promoter and coding sequence polymorphisms in DGAT-I and -2 and ABCAL In Specific Aim 2, the investigators will determine whether the polymorphisms have functional significance by using a luciferase reporter system to determine expression of polymorphic forms of DGAT and ABCAI, a cholesterol efflux measurement to determine the functional significance of ABCAI coding sequence polymorphic sites, and a triglyceride synthesis assay to determine the functional significance of DGAT-I and -2 polymorphic sites. The polymorphic site association studies will be performed on DNA samples from three subgroups of Turks: (a) individuals likely to have the metabolic syndrome, (b) individuals with isolated low HDL-C (normal triglycerides), and (c) normolipidemic unaffected controls.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 1202;
Study Start Date: April 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049881
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Genetic Determinants:Low HDL, High Triglycerides, Obesity
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