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

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

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

19 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Healthy adults with BMI below 32
  • Both males and females
  • Ages 19-60 years
  • Race: African Americans, White Hispanics, European Americans

Description

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 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 adults
healthy adults with BMI below 32, between ages 19-60 yrs, both males and females

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

  • F091023002

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.

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