Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Chromium, Insulin resistance
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.
Interventions
DIETARY_SUPPLEMENTChromium 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.
Sponsors
Universidade Federal de Goias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Sensitivity as assessed with homeostatic model assessment (HOMA) | baseline, 45 days and 90 days |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed