Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
研究概览
简要总结
This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.
详细描述
A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Impaired fasting glucose
- •Adult, age between 18 and 65
- •Serum vitamin D level below 30 ng/mL
排除标准
- •History of nephrolithiasis
- •Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
- •Pregnancy
- •Liver disease
- •Renal disease
结局指标
主要结局
Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
时间窗: At baseline and after 4 weeks of vitamin D supplementation
次要结局
- Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.(One month)
- Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.(One month)