Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
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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 of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Chromium and Insulin Action |
- Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps [ Time Frame: at study enpoints ] [ Designated as safety issue: No ]
- glucose control [ Time Frame: at study endpoints ] [ Designated as safety issue: No ]
- body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans [ Time Frame: at study endpoints ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2003 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
-
Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Louisiana | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
| Principal Investigator: | William Cefalu, MD | Pennington Biomedical Research Center |
More Information
No publications provided by Pennington Biomedical Research Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | William Cefalu, MD, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT00398853 History of Changes |
| Other Study ID Numbers: | 1R01 DK060126 |
| Study First Received: | November 9, 2006 |
| Last Updated: | January 25, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Pennington Biomedical Research Center:
|
insulin glucose chromium |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Chromium Insulin Picolinic acid |
Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hypoglycemic Agents Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013