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Chromium and Insulin Action

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ClinicalTrials.gov Identifier: NCT00283777
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):
William Cefalu, MD, Pennington Biomedical Research Center

Brief Summary:
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 on blood glucose levels and insulin sensitivity

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Chromium Picolinate Phase 4

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 (4). 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, and over a 10 month period of observation, used established techniques to assess changes in insulin sensitivity, body composition and glycemic control.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Chromium Picolinate on Metabolic and Physiologic Parameters in Type 2 Diabetes
Study Start Date : August 1998
Actual Primary Completion Date : January 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Insulin Senstivity, glycated hemoglobin

Secondary Outcome Measures :
  1. weight, body composition

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Type 2 diabetes on diet therapy or low dose oral agent -

Exclusion Criteria:

Significant cardiovascular, hepatic or renal disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283777

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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05410
Sponsors and Collaborators
Pennington Biomedical Research Center
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Principal Investigator: William Cefalu, MD University of Vermont and Pennington Biomedical Research Center
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Responsible Party: William Cefalu, MD, Executive Director, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00283777    
Other Study ID Numbers: PBRC 23041
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Keywords provided by William Cefalu, MD, Pennington Biomedical Research Center:
body weight
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Picolinic acid
Trace Elements
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action