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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01041365
Other study ID # F090824002
Secondary ID
Status Completed
Phase N/A
First received December 28, 2009
Last updated January 13, 2014
Start date December 2009
Est. completion date December 2013

Study information

Verified date January 2014
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in AA is responsible for ethnic differences in insulin sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D.

Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria:

- African American or Caucasian ethnicity

- Ages 14-18 yrs

- Healthy

Exclusion Criteria:

- BMI-for age and -sex higher than 95th centile on the Centers for Disease Control and Prevention Growth Charts

- Use of medication(s) known to influence body composition, vascular function, or glucose metabolism

- Pregnancy

- Diabetes or any chronic diseases

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
United States University of Alabama Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insulin Sensitivity Cross sectional study: at the first study visit No
Secondary Vascular Function Cross sectional study: at the second study visit, within 2 weeks of first study visit No
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