Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls

Obesity Clinical Trial

Official title:

Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls (Assessment of Prevalence of Vitamin D Deficiency in Obese Teenage Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851396
• Other study ID #: F080221001
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: September 9, 2011
• Start date: April 2008
• Est. completion date: October 2010

Study information

• Verified date: September 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to assess the relationship between vitamin D status and insulin- glucose dynamics in obese Adolescents. The study is intended to assess the difference in the insulin sensitivity before and after correction of vitamin D deficiency.

Description:

The vitamin D deficient subjects are identified initially through an existing study. Those identified with vitamin D deficiency are notified and subsequently treated with standard therapy for vitamin D deficiency as part of their clinical care. Patients who self report that they have taken the treatment are enrolled in this study. Patients will be evaluated in this study with measurement of serum 25 OH D level, PTH and oral glucose tolerance test. The study will assess if there is improvement in glucose- insulin sensitivity dynamics once the serum 25OH D level is normalized

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Female adolescents who are menarchal

• BMI is 95th centile, for age and sex

• Patients will be screened for vitamin D deficiency through an existing study.

• Those found to be vitamin D deficient will be given standard treatment of vitamin D deficiency.

• In this study, patients who self report that they had taken the treatment for vitamin D will be screened for serum 25 OH D level

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	Children's Hospital , University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.		December 2009	No
Secondary	We will evaluate whether the relationship of obesity and insulin resistance and the defective insulin secretory capacity is modulated by vitamin D status		December 2009	No