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Vascular Function, Insulin Sensitivity, and Vitamin D (VIVID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01041547
First received: December 28, 2009
Last updated: January 13, 2014
Last verified: January 2014
History of Changes

December 28, 2009
January 13, 2014
December 2009
December 2012   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Cross sectional study: at first study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01041547 on ClinicalTrials.gov Archive Site
Vascular function [ Time Frame: Cross sectional study: at second study visit, within 2 weeks of first study visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vascular Function, Insulin Sensitivity, and Vitamin D
Vitamin D, Vascular Function, and Insulin Sensitivity in Adults [The VIVID Study

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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Seum
Non-Probability Sample
  • Healthy adults with BMI below 32
  • Both males and females
  • Ages 19-60 years
  • Race: African Americans, White Hispanics, European Americans
  • Insulin Sensitivity
  • Flow-mediated Dilation
  • Arterial Stiffness
Not Provided
Healthy adults
healthy adults with BMI below 32, between ages 19-60 yrs, both males and females
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
19 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01041547
F091023002
Yes
Ambika Ashraf, M.D., University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Ambika Ashraf, MD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP