Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

Completed

• Conditions: Vitamin D Deficiency; Obesity; Insulin Resistance

• Registration Number: NCT00850694
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.

Detailed Description

This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-09
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• Female adolescents
• Obese: BMI > 95th percentile
• Menarchal
• Tanner stage ≥ 4

Exclusion Criteria

• Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents.	At study entry

Secondary Outcome Measures

Name	Time	Method
To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP.	At study entry

Trial Locations

Locations (1)

Children's Hospital, Universiy of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States