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Effect of the Chromium Nicotinate on Type 2 Diabetes

U

Universidade Federal de Goias

Status and phase

Unknown
Phase 3

Conditions

Type 2 Diabetes

Treatments

Dietary Supplement: Chromium nicotinate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

57 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Chromium nicotinate
Chromium nicotinate 50 mcg
Active Comparator group
Treatment:
Dietary Supplement: Chromium nicotinate
Chromium nicotinate 200 mcg
Active Comparator group
Treatment:
Dietary Supplement: Chromium nicotinate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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