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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Obesity

• Registration Number: NCT00347542
• Lead Sponsor: Sitaram Bhartia Institute of Science and Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study Start: 2006-07
• Study First Posted: 2006-07-04
• Primary Completion: 2007-09
• Study Completion: 2007-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral Glucose Insulin Sensitivity (OGIS)

Secondary Outcome Measures

Name	Time	Method
ApoA1
ApoB
Blood Pressure
Lipid profile
CRP

Trial Locations

Locations (1)

Sitaram Bhartia Institute of Science and Research; 🇮🇳 New Delhi, Delhi, India