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

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ClinicalTrials.gov Identifier: NCT00850694
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham

Brief Summary:
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 or disease
Vitamin D Deficiency Obesity Insulin Resistance

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.

Study Type : Observational
Actual Enrollment : 114 participants
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
Study Start Date : February 2007
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Group/Cohort
1
Obese female adolescents



Primary Outcome Measures :
  1. To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents. [ Time Frame: At study entry ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: September 2011

Keywords provided by Ambika Ashraf, M.D., University of Alabama at Birmingham:
Vitamin D deficiency
Obesity
Insulin resistance
Glucose tolerance

Additional relevant MeSH terms:
Insulin Resistance
Vitamin D Deficiency
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Insulin
Vitamins
Vitamin D
Ergocalciferols
Hypoglycemic Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents