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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00851396
First received: February 23, 2009
Last updated: September 9, 2011
Last verified: September 2011
  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: Observational Model: Case Control
Time Perspective: 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:


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 ]

Estimated Enrollment: 30
Study Start Date: April 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Ambika Ashraf, M.D., Assistant Professor, Pediatrics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00851396     History of Changes
Other Study ID Numbers: F080221001
Study First Received: February 23, 2009
Last Updated: September 9, 2011
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:
Insulin Resistance
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Malnutrition
Metabolic Diseases
Nutrition Disorders
Ergocalciferols
Insulin
Insulin, Globin Zinc
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Hypoglycemic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014