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临床试验/NCT00320853
NCT00320853已完成不适用

A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity

Sitaram Bhartia Institute of Science and Research2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年4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
30
试验地点
2
主要终点
OGIS Index, Total Insulin Secretion

研究概览

简要总结

The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

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.The available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).We therefore, planned this trial to study the effect of vitamin D supplementation (240,000 IU) on insulin secretion and peripheral insulin sensitivity.This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

Study design and comparison:Single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of Vitamin D. The pre and post intervention results will be compared using the paired t test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • ≥30 years of age
  • Waist circumference ≥80 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

结局指标

主要结局

OGIS Index, Total Insulin Secretion

次要结局

  • HOMA
  • QUICKI
  • ISI composite
  • ISI stumvoll
  • ISI Gutt
  • Insulinogenic Index
  • Lipid profile
  • CRP
  • ApoA1
  • ApoB

研究者

发起方
Sitaram Bhartia Institute of Science and Research
申办方类型
Other

研究点 (2)

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