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

January 13, 2014 updated by: Ambika Ashraf, M.D., University of Alabama at Birmingham

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • University of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy adolescents
Healthy adolescent African American and Caucasian females, ages 14-18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Sensitivity
Time Frame: Cross sectional study: at the first study visit
Cross sectional study: at the first study visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Vascular Function
Time Frame: Cross sectional study: at the second study visit, within 2 weeks of first study visit
Cross sectional study: at the second study visit, within 2 weeks of first study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Ambika Ashraf, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F090824002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Sensitivity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe