Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment chromium nicotinate
Phase phase 3
Sponsor Universidade Federal de Goias
Start date March 2010
End date July 2011
Trial size 57 participants
Trial identifier NCT01368328, DM2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
(Active Comparator)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)
time frame: baseline, 45 days and 90 days

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 30 years up to 60 years old.

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

Additional Information

Official title Effect of Chromium Supplementation on Insulin Sensitivity in Patients With Type 2 Diabetes
Principal investigator Marília Mendonça Guimarães
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Universidade Federal de Goias.