Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

April 7, 2016 updated by: William Cefalu, MD, Pennington Biomedical Research Center

Chromium and Insulin Action

The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed Description:

The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.

One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • On no meds to alter glucose metabolism
  • age greater than 25 years old
  • Fasting glucose greater than 125 mg/dl at screening

Exclusion Criteria:

  • Subjects on insulin
  • Sujbects on meds that alter glucose metabolism
  • Use of glitazones
  • C0-existing disorders in major organ systems such as heart, kidneys, liver

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo
Other: Placebo
Placebo
Experimental: Chromium Picolinate
Chromium
Dietary supplement: chromium picolinate 1000 mcg daily vs placebo
chromium picolinate 1000 mcg daily vs placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps
Time Frame: at study enpoints
at study enpoints

Secondary Outcome Measures

Outcome Measure
Time Frame
glucose control
Time Frame: at study endpoints
at study endpoints
body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans
Time Frame: at study endpoints
at study endpoints

Collaborators and Investigators

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

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: William Cefalu, MD, Pennington Biomedical Research Center

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

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

October 1, 2003

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK060126 (U.S. NIH Grant/Contract)

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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