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

Tracking Information

First Received Date ^ICMJE

December 28, 2009

Last Updated Date

January 13, 2014

Start Date ^ICMJE

December 2009

Primary Completion Date

December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Insulin sensitivity [ Time Frame: Cross sectional study: at first study visit ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01041547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vascular Function, Insulin Sensitivity, and Vitamin D

Official Title ^ICMJE

Vitamin D, Vascular Function, and Insulin Sensitivity in Adults [The VIVID Study

Brief 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 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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Seum

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

Condition ^ICMJE

Insulin Sensitivity
Flow-mediated Dilation
Arterial Stiffness

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Healthy adults

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

Publications *

Alvarez JA, Gower BA, Calhoun DA, Judd SE, Dong Y, Dudenbostel T, Scholl J, Ashraf AP. Serum 25-hydroxyvitamin D and Ethnic Differences in Arterial Stiffness and Endothelial Function. J Clin Med Res. 2012 Jun;4(3):197-205. doi: 10.4021/jocmr965w. Epub 2012 May 15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2013

Primary Completion Date

December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years to 60 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01041547

Other Study ID Numbers ^ICMJE

F091023002

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ambika Ashraf, M.D., University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ambika Ashraf, MD

University of Alabama at Birmingham

PRS Account

University of Alabama at Birmingham

Verification Date

January 2014

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

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