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

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ClinicalTrials.gov Identifier: NCT00374361
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : June 8, 2016
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Robert Hoffman, Ohio State University

Brief Summary:
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 or disease
Diabetes Mellitus, Type 2 Hypertension Heart Disease Stroke

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.


Study Type : Observational
Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship of Endothelial Function to Insulin Sensitivity in African American and Caucasian Adolescents
Study Start Date : July 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Group/Cohort
Caucasian Adolescents
Caucasian Adolescents
African-American Adolescents
African-American Adolescents




Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adolescents
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Chronic Disease
  • Acute Disease
  • Medication Requirement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Robert Hoffman, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00374361     History of Changes
Other Study ID Numbers: ENDO 203
AHA 0355195B ( Other Grant/Funding Number: American Heart Association )
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Observational

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

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs