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

- Insulin Senstivity, glycated hemoglobin
- weight, body composition

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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
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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
United States, Vermont | |
University of Vermont | |
Burlington, Vermont, United States, 05410 |
Principal Investigator: | William Cefalu, MD | University of Vermont and Pennington Biomedical Research Center |
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 |
insulin glucose body weight chromium |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Chromium Picolinic acid |
Trace Elements Micronutrients Physiological Effects of Drugs Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |