Effect of the Chromium Nicotinate on Type 2 Diabetes

Phase 3

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Chromium nicotinate

• Registration Number: NCT01368328
• Lead Sponsor: Universidade Federal de Goias

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Status Verified: 2011-02
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-06-06
• Last Update Submitted: 2011-06-06
• Study First Posted: 2011-06-07
• Last Update Posted: 2011-06-07
• Primary Completion: 2011-07
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chromium nicotinate 50 mcg	Chromium nicotinate	-
Placebo	Chromium nicotinate	-
Chromium nicotinate 200 mcg	Chromium nicotinate	-

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)	baseline, 45 days and 90 days

Secondary Outcome Measures

Name	Time	Method
waist circumference	baseline, 45 days, 90 days
body fat accessed with bioimpedance	baseline, 45 days, 90 days
fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol	baseline, 45 days and 90 days
body weight	baseline, 45 days, 90 days
urea and creatinine	baseline, 45 days, 90 days

Trial Locations

Locations (1)

Goiania Municipal Health Departament; 🇧🇷 Goiânia, Goiás, Brazil