Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008
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
- 是
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
Cholecalciferol 20.000 IU per week for 5 years
干预措施: cholecalciferol (Drug)
2
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)
