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Epidemiology of Cardiovascular Disease in Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037297
First Posted: May 17, 2002
Last Update Posted: July 29, 2016
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.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To locate and identify genes contributing to the genetic component of subclinical cardiovascular disease (CVD) in Type 2 diabetes and to evaluate the impact of lifestyle and environment on the expression of these genetic components of subclinical CVD.

Condition
Cardiovascular Diseases Diabetes Mellitus, Non-insulin Dependent Heart Diseases Atherosclerosis Diabetes Mellitus

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 2001
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Atherosclerosis is the most important complication of diabetes and the reason for its accelerated course in patients with this condition is poorly understood. Diabetes is increasing in prevalence and will exact a heavy disease burden on the United States population over the coming years. Secondary prevention of atherosclerotic complications would be of great value. The rationale underlying genetic studies is that new pathways could be identified through functional genomics.

DESIGN NARRATIVE:

The following hypotheses are tested: 1) The risk of developing Type 2 diabetes-associated cardiovascular disease (CVD) has a significant heritable component that can be measured, and 2) The chromosomal locations of genes contributing to CVD in Type 2 diabetes can be determined and the genes identified using modern molecular genetic approaches. The investigators predict that these genetic factors can be detected in studies of sibling pairs with Type 2 diabetes through genetic epidemiology methods and linkage analysis. Type 2 diabetes-affected sibling pairs, unaffected siblings, and parents, if available, will be recruited and multiple clinical and subclinical measures of subclinical CVD risk will be assessed, including coronary artery calcification (CAC), carotid arterial wall thickness (IMT), ECG variables, and prevalent CVD. Data on the patients are collected in one visit to the General Clinical Research Center (GCRC) which includes an interview and physical examination, a resting 12-lead electrocardiogram (ECG), B-mode ultrasound of the carotid arteries, retrospectively gated helical CT (RGHCT), and a spectrum of clinical laboratory measures. Genetic and epidemiological methods will be used to evaluate the familial aggregation of subclinical CVD taking into consideration the effects of shared environmental exposures (e.g. smoking, diet, alcohol intake and physical activity) and clinical measures (e.g., body mass index, blood pressure, lipids, age, sex, etc.). Initial estimates of heritability suggest a significant heritable component to subclinical CVD. Clinical evaluation will be followed by a comprehensive molecular genetic analysis of the sib pairs/families including a genome wide screen, which will be followed by a focused effort to create a high quality dataset by regenotyping or replacing problem markers. Evidence for linkage to quantitative trait loci (QTLs) influencing CAC and IMT will be pursued in those chromosomal regions showing suggestive evidence for linkage and then performing further analyses to detect associations with these "saturation" markers.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  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): NCT00037297


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Donald Bowden Wake Forest University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00037297     History of Changes
Other Study ID Numbers: 1160
R01HL067348 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2002
First Posted: May 17, 2002
Last Update Posted: July 29, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases