Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049881
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2002-11-14
Brief Title:
Genetic DeterminantsLow HDL High Triglycerides Obesity
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
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 conduct genetic studies of the metabolic syndrome characterized by very low levels of high density lipoprotein cholesterol HDL-C hypertriglyceridemia and obesity
Detailed Description:
BACKGROUND
Over the past 10 years extensive studies have been conducted in Turkey to determine the risk factors for heart disease Studies involving approximately 10000 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 mgdl The mean HDL-C levels are 10-15 mgdl lower than those in Western European or American populations In addition Turks especially Turkish women have a tendency toward obesity 388 percent of the women have body mass index BMI 30 kgM2 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 was in response to a Request for Applications entitled NHLBI Innovative Research Grant Program released in July 2001 The purpose of the initiative was to support new approaches to heart lung and blood diseases and sleep disorders that used existing data sets or existing biological specimen collections whether obtained through National Heart Lung and Blood Institute support or not
DESIGN NARRATIVE
The study analyzed DNA from frozen blood samples to investigate new candidate gene targets that provided insights into the abnormalities characterizing this population of Turks The samples and extensive biodata were available on all 10000 participants In Specific Aim 1 the investigators identified polymorphisms in acyl CoAdiacylglycerol acyltranferase DGAT- I and -2 and in ATP-binding cassette A I ABCA I genes that were associated with differences in BMI HDL-C and triglyceride concentration and other parameters such as blood pressure These studies focussed significantly on promoter and coding sequence polymorphisms in DGAT-I and -2 and ABCAL In Specific Aim 2 the investigators determined whether the polymorphisms had 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 were 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Over the past 10 years extensive studies have been conducted in Turkey to determine the risk factors for heart disease Studies involving approximately 10000 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 mgdl The mean HDL-C levels are 10-15 mgdl lower than those in Western European or American populations In addition Turks especially Turkish women have a tendency toward obesity 388 percent of the women have body mass index BMI 30 kgM2 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 was in response to a Request for Applications entitled NHLBI Innovative Research Grant Program released in July 2001 The purpose of the initiative was to support new approaches to heart lung and blood diseases and sleep disorders that used existing data sets or existing biological specimen collections whether obtained through National Heart Lung and Blood Institute support or not
DESIGN NARRATIVE
The study analyzed DNA from frozen blood samples to investigate new candidate gene targets that provided insights into the abnormalities characterizing this population of Turks The samples and extensive biodata were available on all 10000 participants In Specific Aim 1 the investigators identified polymorphisms in acyl CoAdiacylglycerol acyltranferase DGAT- I and -2 and in ATP-binding cassette A I ABCA I genes that were associated with differences in BMI HDL-C and triglyceride concentration and other parameters such as blood pressure These studies focussed significantly on promoter and coding sequence polymorphisms in DGAT-I and -2 and ABCAL In Specific Aim 2 the investigators determined whether the polymorphisms had 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 were 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL071027 | NIH | None | httpsreporternihgovquickSearchR01HL071027 |