Effect of the Chromium Nicotinate on Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Chromium nicotinate
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Chromium, Insulin resistance
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
Sites / Locations
- Goiania Municipal Health Departament
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Chromium nicotinate 50 mcg
Chromium nicotinate 200 mcg
Arm Description
Outcomes
Primary Outcome Measures
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)
Secondary Outcome Measures
fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol
body weight
body fat accessed with bioimpedance
waist circumference
urea and creatinine
Full Information
NCT ID
NCT01368328
First Posted
April 12, 2011
Last Updated
June 6, 2011
Sponsor
Universidade Federal de Goias
1. Study Identification
Unique Protocol Identification Number
NCT01368328
Brief Title
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
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Goias
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Chromium, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Chromium nicotinate 50 mcg
Arm Type
Active Comparator
Arm Title
Chromium nicotinate 200 mcg
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Chromium nicotinate
Intervention Description
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 Outcome Measure Information:
Title
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)
Time Frame
baseline, 45 days and 90 days
Secondary Outcome Measure Information:
Title
fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Time Frame
baseline, 45 days and 90 days
Title
body weight
Time Frame
baseline, 45 days, 90 days
Title
body fat accessed with bioimpedance
Time Frame
baseline, 45 days, 90 days
Title
waist circumference
Time Frame
baseline, 45 days, 90 days
Title
urea and creatinine
Time Frame
baseline, 45 days, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marília Mendonça Guimarães
Organizational Affiliation
Faculdade de Nutrição - Universidade Federal de Goiás
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Sebastiana Silva
Organizational Affiliation
Faculdade de Educação Física - Universidade Federal de Goiás
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goiania Municipal Health Departament
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74000000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19087394
Citation
Anderson RA. Chromium and insulin resistance. Nutr Res Rev. 2003 Dec;16(2):267-75. doi: 10.1079/NRR200366.
Results Reference
background
PubMed Identifier
17303791
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.
Results Reference
background
PubMed Identifier
16505499
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.
Results Reference
background
PubMed Identifier
16873787
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.
Results Reference
background
PubMed Identifier
12550067
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.
Results Reference
background
Links:
URL
http://www.diabetes.org/
Description
American Diabetes Association
Learn more about this trial
Effect of the Chromium Nicotinate on Type 2 Diabetes
We'll reach out to this number within 24 hrs