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

S

Sitaram Bhartia Institute of Science and Research

Status

Completed

Conditions

Diabetes Mellitus, Non-Insulin-Dependent
Obesity

Treatments

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT00347542
SBISR/2006/03

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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