Effect of the Chromium Nicotinate on Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Universidade Federal de Goias.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT01368328
First received: April 12, 2011
Last updated: June 6, 2011
Last verified: February 2011

April 12, 2011
June 6, 2011
March 2010
July 2011   (final data collection date for primary outcome measure)
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA) [ Time Frame: baseline, 45 days and 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01368328 on ClinicalTrials.gov Archive Site
  • fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol [ Time Frame: baseline, 45 days and 90 days ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: No ]
  • body fat accessed with bioimpedance [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: No ]
  • urea and creatinine [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of the Chromium Nicotinate on Type 2 Diabetes
Effect of Chromium Supplementation on Insulin Sensitivity in Patients With Type 2 Diabetes

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
Dietary Supplement: 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.
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Chromium nicotinate
  • Active Comparator: Chromium nicotinate 50 mcg
    Intervention: Dietary Supplement: Chromium nicotinate
  • Active Comparator: Chromium nicotinate 200 mcg
    Intervention: Dietary Supplement: Chromium nicotinate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01368328
DM2
No
Marília Mendonça Guimarães, Faculdade de Nutrição Universidade Federal de Goiás
Universidade Federal de Goias
Not Provided
Principal Investigator: Marília Mendonça Guimarães Faculdade de Nutrição - Universidade Federal de Goiás
Principal Investigator: Maria Sebastiana Silva Faculdade de Educação Física - Universidade Federal de Goiás
Universidade Federal de Goias
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP