Effect of the Chromium Nicotinate on Type 2 Diabetes

NCT ID: NCT01368328

Last Updated: 2011-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Chromium nicotinate

Intervention Type DIETARY_SUPPLEMENT

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.

Chromium nicotinate 50 mcg

Group Type ACTIVE_COMPARATOR

Chromium nicotinate

Intervention Type DIETARY_SUPPLEMENT

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.

Chromium nicotinate 200 mcg

Group Type ACTIVE_COMPARATOR

Chromium nicotinate

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Goias

OTHER

Sponsor Role lead

Responsible Party

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Faculdade de Nutrição Universidade Federal de Goiás

Principal Investigators

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Marília Mendonça Guimarães

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Nutrição - Universidade Federal de Goiás

Maria Sebastiana Silva

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Educação Física - Universidade Federal de Goiás

Locations

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Goiania Municipal Health Departament

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

References

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Anderson RA. Chromium and insulin resistance. Nutr Res Rev. 2003 Dec;16(2):267-75. doi: 10.1079/NRR200366.

Reference Type BACKGROUND
PMID: 19087394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17303791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16505499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16873787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12550067 (View on PubMed)

Related Links

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http://www.diabetes.org/

American Diabetes Association

Other Identifiers

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DM2

Identifier Type: -

Identifier Source: org_study_id

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