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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Non-Insulin-Dependent Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Vitamin D

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes