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CV Disease in Adolescents With Type 2 Diabetes
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), May 2008
First Received: June 20, 2005   Last Updated: May 14, 2008   History of Changes
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.


Condition Phase
Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Obesity
N/A

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: CV Disease in Adolescents With Type 2 Diabetes

Resource links provided by NLM:


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

Biospecimen Retention:   None Retained

Biospecimen Description:

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)
Detailed Description:

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
Study Population

Three groups of adolescents:

  1. Lean controls
  2. Obese controls (without diabetes)
  3. Obese with diabetes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114998

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    
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas R Kimball, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010