Epidemiology of Cardiovascular Disease in Diabetes
Primary Purpose
Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037297
First Posted
May 16, 2002
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00037297
Brief Title
Epidemiology of Cardiovascular Disease in Diabetes
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases, Atherosclerosis, Diabetes Mellitus
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Bowden
Organizational Affiliation
Wake Forest University
12. IPD Sharing Statement
Citations:
PubMed Identifier
12105369
Citation
Lange LA, Bowden DW, Langefeld CD, Wagenknecht LE, Carr JJ, Rich SS, Riley WA, Freedman BI. Heritability of carotid artery intima-medial thickness in type 2 diabetes. Stroke. 2002 Jul;33(7):1876-81. doi: 10.1161/01.str.0000019909.71547.aa.
Results Reference
background
PubMed Identifier
15549645
Citation
Lenchik L, Hsu FC, Register TC, Lohman KK, Freedman BI, Langefeld CD, Bowden DW, Carr JJ. Heritability of spinal trabecular volumetric bone mineral density measured by QCT in the Diabetes Heart Study. Calcif Tissue Int. 2004 Oct;75(4):305-12. doi: 10.1007/s00223-004-0249-z. Epub 2004 Jul 30.
Results Reference
background
PubMed Identifier
15504984
Citation
Bento JL, Palmer ND, Mychaleckyj JC, Lange LA, Langefeld CD, Rich SS, Freedman BI, Bowden DW. Association of protein tyrosine phosphatase 1B gene polymorphisms with type 2 diabetes. Diabetes. 2004 Nov;53(11):3007-12. doi: 10.2337/diabetes.53.11.3007.
Results Reference
background
PubMed Identifier
15502096
Citation
Register TC, Burdon KP, Lenchik L, Bowden DW, Hawkins GA, Nicklas BJ, Lohman K, Hsu FC, Langefeld CD, Carr JJ. Variability of serum soluble intercellular adhesion molecule-1 measurements attributable to a common polymorphism. Clin Chem. 2004 Nov;50(11):2185-7. doi: 10.1373/clinchem.2004.036806. No abstract available.
Results Reference
background
PubMed Identifier
15872076
Citation
Freedman BI, Langefeld CD, Lohman KK, Bowden DW, Carr JJ, Rich SS, Wagenknecht LE. Relationship between albuminuria and cardiovascular disease in Type 2 diabetes. J Am Soc Nephrol. 2005 Jul;16(7):2156-61. doi: 10.1681/ASN.2004100884. Epub 2005 May 4.
Results Reference
background
PubMed Identifier
15800289
Citation
Hsu FC, Lenchik L, Nicklas BJ, Lohman K, Register TC, Mychaleckyj J, Langefeld CD, Freedman BI, Bowden DW, Carr JJ. Heritability of body composition measured by DXA in the diabetes heart study. Obes Res. 2005 Feb;13(2):312-9. doi: 10.1038/oby.2005.42.
Results Reference
background
PubMed Identifier
15654254
Citation
Wheeler GL, Shi R, Beck SR, Langefeld CD, Lenchik L, Wagenknecht LE, Freedman BI, Rich SS, Bowden DW, Chen MY, Carr JJ. Pericardial and visceral adipose tissues measured volumetrically with computed tomography are highly associated in type 2 diabetic families. Invest Radiol. 2005 Feb;40(2):97-101. doi: 10.1097/00004424-200502000-00007.
Results Reference
background
PubMed Identifier
16155398
Citation
Hsu FC, Zaccaro DJ, Lange LA, Arnett DK, Langefeld CD, Wagenknecht LE, Herrington DM, Beck SR, Freedman BI, Bowden DW, Rich SS. The impact of pedigree structure on heritability estimates for pulse pressure in three studies. Hum Hered. 2005;60(2):63-72. doi: 10.1159/000087971. Epub 2005 Sep 8.
Results Reference
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Epidemiology of Cardiovascular Disease in Diabetes
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