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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041547
First Posted: December 31, 2009
Last Update Posted: January 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
  Purpose

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).


Condition
Insulin Sensitivity Flow-mediated Dilation Arterial Stiffness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vitamin D, Vascular Function, and Insulin Sensitivity in Adults [The VIVID Study

Resource links provided by NLM:


Further study details as provided by Ambika Ashraf, M.D., University of Alabama at Birmingham:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Cross sectional study: at first study visit ]

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

Biospecimen Retention:   Samples Without DNA
Seum

Enrollment: 63
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy adults
healthy adults with BMI below 32, between ages 19-60 yrs, both males and females

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041547


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35243
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Ambika Ashraf, MD University of Alabama at Birmingham
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ambika Ashraf, M.D., Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01041547     History of Changes
Other Study ID Numbers: F091023002
First Submitted: December 28, 2009
First Posted: December 31, 2009
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Ambika Ashraf, M.D., University of Alabama at Birmingham:
Insulin sensitivity
Vascular function
Flow-mediated dilation
Arterial stiffness
Glucose tolerance
Hypertension

Additional relevant MeSH terms:
Hypersensitivity
Insulin Resistance
Dilatation, Pathologic
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathological Conditions, Anatomical
Insulin
Vitamin D
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents