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Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00374361
First received: September 7, 2006
Last updated: September 8, 2006
Last verified: September 2006
History of Changes
  Purpose

This study is designed to determine whether there is a relationship between the way insulin and blood vessels work. The difference in the interaction between Caucasian and African American adolescents will also be examined. This may play a role in the differing rates of heart disease and diabetes between the two groups.


Condition
Diabetes Mellitus, Type 2
Hypertension
Heart Disease
Stroke

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Relationship of Endothelial Function to Insulin Sensitivity in African American and Caucasian Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Estimated Enrollment: 66
Study Start Date: July 2003
Estimated Study Completion Date: June 2006
Detailed Description:

Purpose: The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes, stroke and heart disease.

Healthy adolescents between 8 and 18 years of age are being studied in the Ohio State University General Clinical Research Center. Two visits will be necessary. One will be a screening visit to determine the child's stage of puberty and obtain a medical history. The second will be the study visit. During the latter, blood vessel function will be determined by studying the change in forearm blood flow before and after blood flow to the forearm is stopped. Insulin sensitivity will be determined using glucose water given into a vein.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian or African American adolescent
  • Between 8 and 18 years of age

Exclusion Criteria:

  • Pregnancy
  • Chronic Disease
  • Acute Disease
  • Medication Requirement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374361

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Nationwide Children's Hospital
Investigators
Study Chair: Robert P Hoffman, MD Ohio State University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374361     History of Changes
Other Study ID Numbers: ENDO 203, AHA 0355195B
Study First Received: September 7, 2006
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
insulin sensitivity
endothelial function
adolescence
lipids
puberty

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Hypertension
Stroke
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
 Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013