Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents (DIVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01041365
First received: December 28, 2009
Last updated: January 13, 2014
Last verified: January 2014

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 the first study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01041365 on ClinicalTrials.gov Archive Site
Vascular Function [ Time Frame: Cross sectional study: at the second study visit, within 2 weeks of first study visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents
Serum 25-hydroxyvitamin D, Vascular Functioning, and Insulin Sensitivity in Adolescent Girls [The DIVA Study (Vitamin D, Insulin, and Vascular Associations)] (Pediatric Physician Training in Translational Research)

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).

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

Serum

Non-Probability Sample

Healthy adolescent African American and European American teenagers, ages 14-18, will be recruited form the Birmingham, AL community

  • Insulin Sensitivity
  • Flow-mediated Dilation
  • Arterial Stiffness
Not Provided
Healthy adolescents
Healthy adolescent African American and Caucasian females, ages 14-18
Ashraf AP, Huisingh C, Alvarez JA, Wang X, Gower BA. Insulin resistance indices are inversely associated with vitamin D binding protein concentrations. J Clin Endocrinol Metab. 2014 Jan;99(1):178-83. doi: 10.1210/jc.2013-2452. Epub 2013 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
14 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01041365
F090824002
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