A Phase 3 interventional study of Chromium nicotinate in Type 2 Diabetes, sponsored by Universidade Federal de Goias. Status unknown at 1 site in Brazil. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-06-07.
Sponsored by Universidade Federal de Goias · Phase 3, Interventional, and Treatment
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 57 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Universidade Federal de Goias is the lead sponsor of 42 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Chromium nicotinate
Dietary Supplement: Chromium nicotinate
Dietary Supplement: Chromium nicotinate
The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)
Time frame: baseline, 45 days and 90 days
fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Time frame: baseline, 45 days and 90 days
body weight
Time frame: baseline, 45 days, 90 days
body fat accessed with bioimpedance
Time frame: baseline, 45 days, 90 days
waist circumference
Time frame: baseline, 45 days, 90 days
urea and creatinine
Time frame: baseline, 45 days, 90 days
This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chromium nicotinic acid complex
Universidade Federal de Goias