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Clinical Trials/NCT01368328
NCT01368328UnknownPhase 3

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

Universidade Federal de Goias2 sites in 1 country57 target enrollmentStarted: March 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
57
Locations
2
Primary Endpoint
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)

Time Frame: baseline, 45 days and 90 days

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (2)

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