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临床试验/NCT00685594
NCT00685594已完成2 期

Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008

University of Tromso1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
511
试验地点
1
主要终点
development of diabetes type 2

研究概览

简要总结

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Impaired glucose tolerance

排除标准

  • Serious heart disease
  • Renal stone disease
  • Hypercalcemia
  • Sarcoidosis

研究组 & 干预措施

1

Experimental

Cholecalciferol 20.000 IU per week for 5 years

干预措施: cholecalciferol (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

development of diabetes type 2

时间窗: 5 years

次要结局

  • change in intima media thickness carotid artery(5 years)
  • change in mood(5 years)
  • change in BMD hip(5 years)
  • change in HbA1c(5 years)
  • change in telomer length(5 years)
  • change in blood pressure(5 years)
  • change in frequency of infections(5 years)
  • change in glucose metabolism(5 years)
  • change in lipid status(5 years)
  • change in weight(5 years)
  • Change in Insulin sensitivity(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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