A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Sponsor
- Sitaram Bhartia Institute of Science and Research
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Oral Glucose Insulin Sensitivity (OGIS)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Dr Jitender Nagpal
Dr Jitender Nagpal
Sitaram Bhartia Institute of Science and Research
Eligibility Criteria
Inclusion Criteria
- •≥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
Outcomes
Primary Outcomes
Oral Glucose Insulin Sensitivity (OGIS)
Secondary Outcomes
- ApoA1
- ApoB
- Blood Pressure
- Lipid profile
- CRP