Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents

Insulin Sensitivity Clinical Trial

— DIVA  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041365
• Other study ID #: F090824002
• 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

Related Conditions & MeSH terms

• Arterial Stiffness
• Flow-mediated Dilation
• Insulin Resistance
• Insulin Sensitivity

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