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

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ClinicalTrials.gov Identifier: NCT00851396
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : September 12, 2011
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham

February 23, 2009
February 25, 2009
September 12, 2011
April 2008
October 2010   (Final data collection date for primary outcome measure)
The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study. [ Time Frame: December 2009 ]
Same as current
Complete list of historical versions of study NCT00851396 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
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Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls
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.
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
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Female adolescents who are menarchal BMI is 95th centile, for age and sex
  • Vitamin D Deficiency
  • Insulin Resistance
  • Insulin Sensitivity
  • Obesity
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
October 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
13 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00851396
F080221001
No
Not Provided
Not Provided
Ambika Ashraf, M.D., University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Ambika Ashraf University of Alabama at Birmingham
University of Alabama at Birmingham
September 2011