CV Disease in Adolescents With Type 2 Diabetes
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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.
| Condition |
|---|
|
Cardiovascular Diseases Diabetes Mellitus Heart Diseases Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | CV Disease in Adolescents With Type 2 Diabetes |
| Enrollment: | 750 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (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:
- Lean controls
- Obese controls (without diabetes)
- Obese with diabetes
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:
- Diabetes, type 2
- Obese
Exclusion Criteria:
- Diabetes, type 1
Contacts and Locations| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Principal Investigator: | Thomas R Kimball, MD | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| Responsible Party: | Tom Kimball, Professor of Pediatrics, Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00114998 History of Changes |
| Other Study ID Numbers: | 1294, R01HL076269 |
| Study First Received: | June 20, 2005 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Obesity Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013