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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00114998 |
Purpose
To study cardiac and vascular structure and function in a population of adolescents with type 2 diabetes mellitus (T2DM) compared to a similar group with obesity alone and a similar non-obese group.
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | CV Disease in Adolescents With Type 2 Diabetes |
| Estimated Enrollment: | 900 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
BACKGROUND:
The prevalence of type 2 diabetes mellitus has increased dramatically in adolescents. This appears to be a direct result of the increase in prevalence and severity of obesity in the pediatric population. In adults with type 2 diabetes, it is well known that the risk for cardiovascular disease (CVD) is quite high. This has led to current clinical recommendation that adults with diabetes be considered equivalent in risk to those adults who already have existing coronary artery disease. It is not known if adolescents with type 2 diabetes have an equivalent high level of risk of CVD as the adult population. If they do then it would be expected that they would develop clinical CVD in their late 20's or 30's. This would have important clinical implications and would suggest the need for very aggressive management of CVD risk factors and diabetes.
DESIGN NARRATIVE:
The study is a cross-sectional evaluation of cardiac and vascular structure and function in a population of adolescents with type 2 diabetes compared to a group with similar age, sex, race and BMI with obesity alone and a non obese group with similar age, sex and race. 300 subjects with type 2 diabetes, 300 subjects with obesity and 300 non obese subjects will be studied. Assessment of CVD development will be accomplished using novel non invasive imaging methods for subclinical atherosclerosis including echocardiographic measurement of cardiac structure and function, ultrasound evaluation of carotid intimal medial thickness, and evaluation of endothelial function by brachial artery reactivity. The primary hypothesis is that adolescents with type 2 diabetes will have greater abnormality in cardiac and vascular structure and function compared to controls with obesity. Subjects with obesity alone will have greater abnormality in cardiac and vascular structure and function compared to controls who are not obese. Correlates of cardiac and vascular abnormalities including markers of inflammation, adiponectin, diet and physical activity will also be evaluated.
Eligibility| Ages Eligible for Study: | 10 Years to 23 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Three groups of adolescents:
An estimated 300 subjects, ages 10 to 23, with type 2 diabetes, 300 subjects with obesity and 300 non-obese subjects will be studied.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Thomas R Kimball, MD 513-636-8270 tkimball@cchmc.org | |
| Principal Investigator: | Thomas R Kimball, MD | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Cincinnati Children's Hospital ( Thomas R. Kimball, M.D. ) |
| Study ID Numbers: | 1294 |
| Study First Received: | June 20, 2005 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00114998 History of Changes |
| Health Authority: | United States: Federal Government |
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Obesity Heart Diseases Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight |
Signs and Symptoms Diabetes Mellitus, Type 2 Nutrition Disorders Cardiovascular Diseases Overnutrition Glucose Metabolism Disorders |