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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00851396

Enrollment

Registered

2009-02-25

Start date

2008-04-30

Completion date

2010-10-31

Last updated

2011-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Insulin Sensitivity, Obesity, Vitamin D Deficiency

Keywords

Vitamin D deficiency, Insulin resistance, Glucose- Insulin dynamics, Obese adolescents

Brief summary

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.

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.	December 2009

Secondary

Measure	Time frame
We will evaluate whether the relationship of obesity and insulin resistance and the defective insulin secretory capacity is modulated by vitamin D status	December 2009

Countries

United States

Outcome results