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

Tracking Information
First Submitted Date	December 28, 2009
First Posted Date	December 31, 2009
Last Update Posted Date	January 14, 2014
Study Start Date	December 2009
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 30, 2009)	Insulin sensitivity [ Time Frame: Cross sectional study: at first study visit ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01041547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: December 30, 2009)	Vascular function [ Time Frame: Cross sectional study: at second study visit, within 2 weeks of first study visit ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Vascular Function, Insulin Sensitivity, and Vitamin D
Official Title	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	Observational
Study Design	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	Insulin Sensitivity; Flow-mediated Dilation; Arterial Stiffness
Intervention	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	Completed
Actual Enrollment; (submitted: December 30, 2009)	63
Original Estimated Enrollment	Same as current
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria	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	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01041547
Other Study ID Numbers	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	University of Alabama at Birmingham
Collaborators	Not Provided
Investigators	Principal Investigator: Ambika Ashraf, MD University of Alabama at Birmingham
PRS Account	University of Alabama at Birmingham
Verification Date	January 2014