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

NCT ID: NCT00851396

Last Updated: 2011-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Vitamin D Deficiency Insulin Resistance Insulin Sensitivity Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Ambika Ashraf, M.D.

Assistant Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ambika Ashraf

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Children's Hospital , University of Alabama

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F080221001

Identifier Type: -

Identifier Source: org_study_id

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