NCT00374361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

2.9 years

First QC Date

September 7, 2006

Last Update Submit

June 6, 2016

Conditions

Keywords

insulin sensitivityendothelial functionadolescencelipidspuberty

Study Arms (2)

Caucasian Adolescents

Caucasian Adolescents

African-American Adolescents

African-American Adolescents

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Adolescents

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Chronic Disease
  • Acute Disease
  • Medication Requirement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionHeart DiseasesStrokeInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHyperinsulinism

Study Officials

  • Robert P Hoffman, MD

    Ohio State University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 11, 2006

Study Start

July 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 8, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Observational

Locations