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Completed

NCT Number: NCT01041365

Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents

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 AA is responsible for ethnic differences in insulin sensitivity and hypertension in AA and 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 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), 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 Diabetes Mellitus Endocrine System Diseases Flow-mediated Dilation Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

14 year–18 year

Sex eligibility

Female

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 or Caucasian ethnicity
  • Ages 14-18 yrs
  • Healthy

Exclusion criteria

  • BMI-for age and -sex higher than 95th centile on the Centers for Disease Control and Prevention Growth Charts
  • Use of medication(s) known to influence body composition, vascular function, or glucose metabolism
  • Pregnancy
  • Diabetes or any chronic diseases

Treatment and study plan

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Cross sectional study: at the first study visit

Secondary outcomes

  1. Vascular Function

    Time frame: Cross sectional study: at the 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

Serum 25-hydroxyvitamin D, Vascular Functioning, and Insulin Sensitivity in Adolescent Girls [The DIVA Study (Vitamin D, Insulin, and Vascular Associations)] (Pediatric Physician Training in Translational Research)

Acronym: DIVA

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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