Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls
This study has been completed.
Sponsor:
University of Alabama at Birmingham
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
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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
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 Obesity Vitamin D Deficiency Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Avitaminosis |
Deficiency Diseases Malnutrition Vitamin D Ergocalciferols Vitamins Insulin Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 16, 2013