Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls - Full Text View

Sponsor:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00851396

Purpose

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.

Condition
Vitamin D Deficiency Insulin Resistance Insulin Sensitivity Obesity

Study Type:	Observational
Study Design:	Case Control, Prospective
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)

Resource links provided by NLM:

MedlinePlus related topics: Obesity Obesity in Children

Drug Information available for: Insulin Vitamin D

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Groups/Cohorts

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.

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

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851396

Locations

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

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator:

Ambika Ashraf

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama ( Ambika P Ashraf )
Study ID Numbers:	F080221001
Study First Received:	February 23, 2009
Last Updated:	December 28, 2009
ClinicalTrials.gov Identifier:	NCT00851396 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Vitamin D deficiency
Insulin resistance
Glucose- Insulin dynamics
Obese adolescents

Additional relevant MeSH terms:

Vitamin D Deficiency
Obesity
Metabolic Diseases
Avitaminosis
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Bone Density Conservation Agents
Overweight
Pharmacologic Actions
Insulin
Body Weight

Hyperinsulinism
Signs and Symptoms
Hypoglycemic Agents
Vitamin D
Malnutrition
Vitamins
Nutrition Disorders
Overnutrition
Micronutrients
Insulin Resistance
Glucose Metabolism Disorders
Deficiency Diseases

ClinicalTrials.gov processed this record on February 08, 2010