跳至主要内容
临床试验/NCT01709123
NCT01709123已完成不适用

Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients

Louisiana State University Health Sciences Center Shreveport1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2007年8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
发起方
入组人数
62
试验地点
1
主要终点
Blood Glucose Level

研究概览

简要总结

6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the devastating complications that result from poorly controlled diabetes. However, for many patients, achievement of tight glucose control is difficult with current regimens. Trivalent chromium, the form found in foods and dietary supplements, is believed to be safe. Our preliminary studies have reported that chromium supplementation inhibits the increase in pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly, animal studies have shown that chromium niacinate supplementation lowered blood levels of glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines are proteins that are secreted by monocytes and other cells in response to various stimuli, such as infection. Some of the cytokines are known to regulate insulin sensitivity and elevated level of these cytokines in blood may accelerate clogging of arteries. Thus, chromium supplementation may increase insulin sensitivity and glycemic control in diabetic patients, and may prevent the development of cardiovascular disease in diabetic patients. Given the enormous public health cost of diabetes, the prospect of being able to use a relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in achieving normal blood glucose level merits further study.

We will examine the effects of placebo and chromium niacinate supplementation on the fasting glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic patients. We will determine these above parameters at baseline and after the 1, 2 and 3 months of supplementation in diabetic patients. The long-term objective is to explore the efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the development of cardiovascular disease (CVD), and improve the life expectancy in diabetic population.

Chromium supplements are widely used by the public and are available in many stores, such as Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an essential vitamin for our body. This study plans to use chromium niacinate, a complex of chromium and niacin. Chromium niacinate is considered a nutrient.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
8 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Type 1 diabetes mellitus
  • Participants between the ages of 8 and 21

排除标准

  • Subjects with sickle cell disease, renal or liver disease
  • Serum positive pregnancy test or breastfeeding
  • Participants unwilling/unable to take supplements in pill form
  • Participants taking prescription medication or supplements

研究组 & 干预措施

placebo

Placebo Comparator

Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.

干预措施: placebo (Drug)

chromium niacinate

Experimental

Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period

干预措施: chromium niacinate (Drug)

结局指标

主要结局

Blood Glucose Level

时间窗: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.

Blood Glucose Levels

时间窗: Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.

Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.

次要结局

  • Lipid Levels(Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.)
  • Blood Levels of Cytokines/Inflammatory Biomarkers(Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.)

研究者

发起方
Louisiana State University Health Sciences Center Shreveport
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验