Effect of the Chromium Nicotinate on Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Chromium nicotinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Body mass index > 25 kg/m2 Increased waist circumference Exclusion Criteria: Subjects on insulin Pregnancy Patients with chronic complications as heart disease, nephropathy, retinopathy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Chromium nicotinate<br>* 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.<br>|
| Active Comparator: Chromium nicotinate 50 mcg<br> | Dietary Supplement: Chromium nicotinate<br>* 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.<br>|
| Active Comparator: Chromium nicotinate 200 mcg<br> | Dietary Supplement: Chromium nicotinate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity as assessed with homeostatic model assessment (HOMA) |  | baseline, 45 days and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Chromium, Insulin resistance