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Completed

NCT Number: NCT01041547

Vascular Function, Insulin Sensitivity, and Vitamin D

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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Key information

Conditions

Insulin Sensitivity Arterial Stiffness Cardiovascular Diseases Flow-mediated Dilation Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama

Birmingham, Alabama, 35243, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Insulin sensitivity

    Time frame: Cross sectional study: at first study visit

Secondary outcomes

  1. Vascular function

    Time frame: Cross sectional study: at second study visit, within 2 weeks of first study visit

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: VIVID

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Dec 31, 2009
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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