Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00850694
First received: February 23, 2009
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.


Condition
Vitamin D Deficiency
Obesity
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Prevalence of Vitamin D Deficiency in Obese Adolescent 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:
  • To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents. [ Time Frame: At study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP. [ Time Frame: At study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Obese female adolescents

Detailed Description:

This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese female adolescents

Criteria

Inclusion Criteria:

  • Female adolescents
  • Obese: BMI > 95th percentile
  • Menarchal
  • Tanner stage ≥ 4

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00850694

Locations
United States, Alabama
Children's Hospital, Universiy of Alabama at Birmingham
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: NCT00850694     History of Changes
Other Study ID Numbers: F061228001
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
Obesity
Insulin resistance
Glucose tolerance

Additional relevant MeSH terms:
Obesity
Insulin Resistance
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 July 22, 2014