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临床试验/NCT00347542
NCT00347542已完成不适用

A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men

Sitaram Bhartia Institute of Science and Research2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年7月1日最近更新:
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相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Oral Glucose Insulin Sensitivity (OGIS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Oral Glucose Insulin Sensitivity (OGIS)

次要结局

  • ApoA1
  • ApoB
  • Blood Pressure
  • Lipid profile
  • CRP

研究者

发起方
Sitaram Bhartia Institute of Science and Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jitender Nagpal

Dr Jitender Nagpal

Sitaram Bhartia Institute of Science and Research

研究点 (2)

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