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

September 9, 2011 updated by: Ambika Ashraf, M.D., University of Alabama at Birmingham

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)

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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's Hospital , University of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female adolescents who are menarchal BMI is 95th centile, for age and sex

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obese female adolescents
Obese adolescents 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 and will undergo OGTT. The OGTT results as well as insulin resistance indices will be compared to their initial values.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.
Time Frame: December 2009
December 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
We will evaluate whether the relationship of obesity and insulin resistance and the defective insulin secretory capacity is modulated by vitamin D status
Time Frame: December 2009
December 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Ambika Ashraf, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F080221001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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