CV Disease in Adolescents With Type 2 Diabetes

Obesity Clinical Trial

Official title:

CV Disease in Adolescents With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114998
• Other study ID #: 1294
• Secondary ID: R01HL076269
• Status: Completed
• Phase: N/A
• First received: June 20, 2005
• Last updated: July 31, 2012
• Start date: June 2005
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 23 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Heart Diseases
• Obesity

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,