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A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier:
NCT00347542
First received: June 30, 2006
Last updated: May 31, 2013
Last verified: May 2013

June 30, 2006
May 31, 2013
July 2006
September 2007   (final data collection date for primary outcome measure)
Oral Glucose Insulin Sensitivity (OGIS)
Same as current
Complete list of historical versions of study NCT00347542 on ClinicalTrials.gov Archive Site
  • Lipid profile
  • CRP
  • ApoA1
  • ApoB
  • Blood Pressure
Same as current
Not Provided
Not Provided
 
A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men
A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men

The purpose of the study is to evaluate the change in glucose and insulin metabolism(early markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.These results have been replicated in patients at risk for diabetes with documentation of impairment in insulin secretion in Vitamin D deficient subjects. Therefore, vitamin D could be implicated in the pathogenesis of type 2 diabetes, by affecting either insulin sensitivity or ß cell function, or both. However, there is paucity of literature on the effect of Vitamin D supplementation on insulin resistance or glucose metabolism. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Obesity
Drug: Vitamin D
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • ≥35 years of age
  • Waist circumference ≥78 cm

Exclusion Criteria:

  • Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
  • BP>140/90 or on anti-hypertensive medication
  • Receiving Vitamin D or calcium supplementation
  • Chronic disease-renal/hepatic/malignancy/gastrointestinal
  • On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
  • Febrile illness or infective morbidity in the past 10 days
  • Past history of nephrolithiasis
Male
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00347542
SBISR/2006/03
Not Provided
Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
Sitaram Bhartia Institute of Science and Research
Not Provided
Principal Investigator: Jitendra N Pande, MD Sitaram Bhartia Institute of Science and Research
Principal Investigator: Jitender Nagpal, MD Sitaram Bhartia Institute of Science and Research
Study Chair: Anupama Singh, MD Sitaram Bhartia Institute of Science and Research
Study Director: Abhishek Bhartia, ME Sitaram Bhartia Institute of Science and Research
Sitaram Bhartia Institute of Science and Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP