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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

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Chromium, Insulin resistance

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Goiania Municipal Health Departament

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo 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

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

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

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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

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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

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Links:

URL

http://www.diabetes.org/

Description

American Diabetes Association

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Effect of the Chromium Nicotinate on Type 2 Diabetes

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