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Completed

NCT Number: NCT00851396

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Body Weight Deficiency Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hospital , University of Alabama

Birmingham, Alabama, 35233, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.

    Time frame: December 2009

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2009
Registry last updated
Sep 12, 2011

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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