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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01041547
Other study ID # F091023002
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 African Americans (AA) and White Hispanics (WH) is responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and European Americans (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 and WH 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), White Hispanics (WH), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 60 Years
Eligibility Inclusion Criteria:

- African American (AA), White Hispanic (WH), and European American (EA) race

- Ages 19-60 years

- Negative urine pregnancy test

- No evidence of diabetes

- Not on medications that can affect vascular functioning or insulin sensitivity

Exclusion Criteria:

- BMI > 32 kg/m2

- Diabetes or any chronic diseases

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

- Regular smoking

- Regular use of illegal drugs and pregnancy

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 first study visit No
Secondary Vascular function Cross sectional study: at second study visit, within 2 weeks of first study visit No
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