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临床试验/NCT01368328
NCT01368328Unknown3 期

Effect of Chromium Supplementation on Insulin Sensitivity in Patients With Type 2 Diabetes

Universidade Federal de Goias2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
3 期
入组人数
57
试验地点
2
主要终点
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)

研究概览

简要总结

The role of micronutrients in diabetes is not well understood. Studies have demonstrated the relationship between low chromium serum levels and insulin resistance. This study aims to evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with type 2 diabetes.

详细描述

Insulin is a hormone secreted by cells β of pancreatic islets in response to increased levels of glucose and serum amino acids. Insulin resistance means a decrease in the ability of insulin to stimulate glucose utilization because is disabled in the insulin receptor, decrease in concentration of receptors or failure mechanism of cell transit. Recently, the discovery of a substance called low molecular weight chromium-binding substance (LMWCr), showed the ability of this substance in amplifying insulin signaling, increasing the sensitivity of insulin receptors in the plasma membrane. This way, the capacity of LMWCr in activating the insulin receptor depends on levels of serum chromium. Thus, the hypothesis that the nutritional status of individual poor chromium contributes to the decrease in glucose tolerance and consequently, for type 2 Diabetes. Thus, it becomes necessary to assess the effect of supplementation of chromium in increased insulin sensitivity in patients with type 2 Diabetes. This is a double-blind randomized clinical trial, consisting of a period of three months of nutritional intervention with chromium nicotinate, biochemical and anthropometric evaluation and assessment of food profile and physical activity.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • Body mass index > 25 kg/m2
  • Increased waist circumference

排除标准

  • Subjects on insulin
  • Pregnancy
  • Patients with chronic complications as heart disease, nephropathy, retinopathy

结局指标

主要结局

Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)

时间窗: baseline, 45 days and 90 days

次要结局

  • fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol(baseline, 45 days and 90 days)
  • body weight(baseline, 45 days, 90 days)
  • body fat accessed with bioimpedance(baseline, 45 days, 90 days)
  • waist circumference(baseline, 45 days, 90 days)
  • urea and creatinine(baseline, 45 days, 90 days)

研究者

申办方类型
Other

研究点 (2)

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