Clinical trial NCT01368328: Effect of the Chromium Nicotinate on Type 2 Diabetes
Official title: Effect of Chromium Supplementation on Insulin Sensitivity in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Chromium
Insulin resistance
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 57
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)
timeFrame: baseline, 45 days and 90 days
Secondary outcomes:
measure: fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol
timeFrame: baseline, 45 days and 90 days
measure: body weight
timeFrame: baseline, 45 days, 90 days
measure: body fat accessed with bioimpedance
timeFrame: baseline, 45 days, 90 days
measure: waist circumference
timeFrame: baseline, 45 days, 90 days
measure: urea and creatinine
timeFrame: baseline, 45 days, 90 days
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Goiania Municipal Health Departament
state: Goiás
Study officials:
affiliation: Faculdade de Nutrição - Universidade Federal de Goiás
name: Marília Mendonça Guimarães
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Educação Física - Universidade Federal de Goiás
name: Maria Sebastiana Silva
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson RA. Chromium and insulin resistance. Nutr Res Rev. 2003 Dec;16(2):267-75. doi: 10.1079/NRR200366.
citation: Kleefstra N, Houweling ST, Bakker SJ, Verhoeven S, Gans RO, Meyboom-de Jong B, Bilo HJ. Chromium treatment has no effect in patients with type 2 diabetes in a Western population: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2007 May;30(5):1092-6. doi: 10.2337/dc06-2192. Epub 2007 Feb 15.
citation: Kleefstra N, Houweling ST, Jansman FG, Groenier KH, Gans RO, Meyboom-de Jong B, Bakker SJ, Bilo HJ. Chromium treatment has no effect in patients with poorly controlled, insulin-treated type 2 diabetes in an obese Western population: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2006 Mar;29(3):521-5. doi: 10.2337/diacare.29.03.06.dc05-1453.
citation: Martin J, Wang ZQ, Zhang XH, Wachtel D, Volaufova J, Matthews DE, Cefalu WT. Chromium picolinate supplementation attenuates body weight gain and increases insulin sensitivity in subjects with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1826-32. doi: 10.2337/dc06-0254.
citation: Ghosh D, Bhattacharya B, Mukherjee B, Manna B, Sinha M, Chowdhury J, Chowdhury S. Role of chromium supplementation in Indians with type 2 diabetes mellitus. J Nutr Biochem. 2002 Nov;13(11):690-697. doi: 10.1016/s0955-2863(02)00220-6.