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临床试验/NCT00283777
NCT00283777已完成4 期

Effect of Chromium Picolinate on Metabolic and Physiologic Parameters in Type 2 Diabetes

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 1998年8月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Insulin Senstivity, glycated hemoglobin

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 on blood glucose levels and insulin sensitivity

详细描述

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 (4). 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, and over a 10 month period of observation, used established techniques to assess changes in insulin sensitivity, body composition and glycemic control.

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

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes on diet therapy or low dose oral agent -

排除标准

  • Significant cardiovascular, hepatic or renal disease

结局指标

主要结局

Insulin Senstivity, glycated hemoglobin

次要结局

  • weight, body composition

研究者

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

William Cefalu, MD

Executive Director

Pennington Biomedical Research Center

研究点 (2)

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