Effect of the Chromium Nicotinate on Type 2 Diabetes

June 6, 2011 updated by: Universidade Federal de Goias

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goiás
      • Goiânia, Goiás, Brazil, 74000000
        • Goiania Municipal Health Departament

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Active Comparator: Chromium nicotinate 50 mcg
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.
Active Comparator: Chromium nicotinate 200 mcg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)
Time Frame: baseline, 45 days and 90 days
baseline, 45 days and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Time Frame: baseline, 45 days and 90 days
baseline, 45 days and 90 days
body weight
Time Frame: baseline, 45 days, 90 days
baseline, 45 days, 90 days
body fat accessed with bioimpedance
Time Frame: baseline, 45 days, 90 days
baseline, 45 days, 90 days
waist circumference
Time Frame: baseline, 45 days, 90 days
baseline, 45 days, 90 days
urea and creatinine
Time Frame: baseline, 45 days, 90 days
baseline, 45 days, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 7, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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