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CV Disease in Adolescents With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tom Kimball, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00114998
First received: June 20, 2005
Last updated: July 31, 2012
Last verified: July 2012

June 20, 2005
July 31, 2012
June 2005
June 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00114998 on ClinicalTrials.gov Archive Site
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CV Disease in Adolescents With Type 2 Diabetes
CV Disease in Adolescents With Type 2 Diabetes

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Three groups of adolescents:

  1. Lean controls
  2. Obese controls (without diabetes)
  3. Obese with diabetes
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Heart Diseases
  • Obesity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
10 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00114998
1294, R01HL076269
No
Tom Kimball, Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Thomas R Kimball, MD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP