跳至主要内容
临床试验/NCT00398853
NCT00398853已完成4 期

Chromium and Insulin Action

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
2
主要终点
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps

研究概览

简要总结

The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps

详细描述

Detailed Description:

The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.

One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Type 2 diabetes
  • On no meds to alter glucose metabolism
  • age greater than 25 years old
  • Fasting glucose greater than 125 mg/dl at screening

排除标准

  • Subjects on insulin
  • Sujbects on meds that alter glucose metabolism
  • Use of glitazones
  • C0-existing disorders in major organ systems such as heart, kidneys, liver

结局指标

主要结局

Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps

时间窗: at study enpoints

次要结局

  • glucose control(at study endpoints)
  • body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans(at study endpoints)

研究者

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

William Cefalu, MD

Principal Investigator

Pennington Biomedical Research Center

研究点 (2)

Loading locations...

相似试验

Effect of Chromium Picolinate on Insulin Sensitivity... | 临床试验