Clinical trial NCT00374361: Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents
Official title: Relationship of Endothelial Function to Insulin Sensitivity in African American and Caucasian Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Hypertension
Heart Disease
Stroke
Keywords: insulin sensitivity
endothelial function
adolescence
lipids
puberty
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2006-09-11
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescents

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy
* Chronic Disease
* Acute Disease
* Medication Requirement

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Robert P Hoffman, MD
role: STUDY_CHAIR
References:
citation: Hoffman RP. Indices of insulin action calculated from fasting glucose and insulin reflect hepatic, not peripheral, insulin sensitivity in African-American and Caucasian adolescents. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):57-61. doi: 10.1111/j.1399-5448.2007.00350.x. Epub 2008 Jan 21.
citation: Duck MM, Hoffman RP. Impaired endothelial function in healthy African-American adolescents compared with Caucasians. J Pediatr. 2007 Apr;150(4):400-6. doi: 10.1016/j.jpeds.2006.12.034.
citation: Hoffman RP. Increased fasting triglyceride levels are associated with hepatic insulin resistance in Caucasian but not African-American adolescents. Diabetes Care. 2006 Jun;29(6):1402-4. doi: 10.2337/dc06-2460. No abstract available.
citation: Xie L, Hoffman RP, Veng-Pedersen P. Noncompartmental pharmacokinetics analysis of glucose-stimulated insulin response in African-American and Caucasian youths. Biopharm Drug Dispos. 2009 Apr;30(3):117-25. doi: 10.1002/bdd.652.