跳至主要内容
临床试验/NCT00876928
NCT00876928已完成不适用

Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population

Charles Drew University of Medicine and Science1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
1
主要终点
Percent of Subjects Who Develop Diabetes

研究概览

简要总结

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

详细描述

Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.

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 (Participant, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than
  • Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
  • Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
  • Serum 25-OHD less than 30 ng/ml
  • Able and willing to provide informed consent

排除标准

  • FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
  • Major psychiatric disorder on medication (excluding successfully treated depression)
  • Diagnosed diabetes mellitus
  • Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
  • History of carcinoma, except skin basal cell or squamous cell skin carcinomas
  • Heart failure, unstable angina or history of a myocardial infarction
  • Alcohol or substance abuse
  • Current treatment with glucocorticoids
  • Current treatment with diabetes medications, including metformin
  • Cushing's syndrome
  • Primary hyperparathyroidism
  • Nephrolithiasis
  • Pregnancy or breast-feeding
  • Regular visits to a tanning salon (unlikely in this minority population)

研究组 & 干预措施

vitamin D

Experimental

Subjects with low vitamin D levels and pre-diabetes

干预措施: vitamin D (Drug)

Placebo

Placebo Comparator

Subjects with low vitamin D levels and pre-diabetes

干预措施: placebo (Drug)

结局指标

主要结局

Percent of Subjects Who Develop Diabetes

时间窗: one year

Diabetes defined by a FPG\>=126 mg/dl or a 2-hr glucose concentration on an OGTT of \>=200 mg/dl

次要结局

  • Disposition Index(Baseline, 3, 6, 9, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mayer Davidson

Professor of Medicine

Charles Drew University of Medicine and Science

研究点 (1)

Loading locations...

相似试验