Vascular Function, Insulin Sensitivity, and Vitamin D (VIVID)
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ClinicalTrials.gov Identifier: NCT01041547 |
Recruitment Status
:
Completed
First Posted
: December 31, 2009
Last Update Posted
: January 14, 2014
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Tracking Information | ||||
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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 |
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 |
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). |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Seum |
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Sampling Method | Non-Probability Sample | |||
Study Population |
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Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Healthy adults
healthy adults with BMI below 32, between ages 19-60 yrs, both males and females |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | University of Alabama at Birmingham | |||
Verification Date | January 2014 |