Chromium and Insulin Action
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Chromium Picolinate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effect of Chromium Picolinate on Metabolic and Physiologic Parameters in Type 2 Diabetes |
- Insulin Senstivity, glycated hemoglobin
- weight, body composition
| Estimated Enrollment: | 30 |
| Study Start Date: | August 1998 |
| Estimated Study Completion Date: | April 2003 |
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.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
-
Contacts and Locations| United States, Vermont | |
| University of Vermont | |
| Burlington, Vermont, United States, 05410 | |
| Principal Investigator: | William Cefalu, MD | University of Vermont and Pennington Biomedical Research Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00283777 History of Changes |
| Other Study ID Numbers: | R55 DK060126 |
| Study First Received: | January 26, 2006 |
| Last Updated: | January 26, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pennington Biomedical Research Center:
|
insulin glucose body weight chromium |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Chromium Picolinic acid Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013