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Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00398853
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : April 8, 2016
Sponsor:
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 of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo Other: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chromium and Insulin Action
Study Start Date : October 2003
Primary Completion Date : April 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Chromium Picolinate
Chromium
Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo
chromium picolinate 1000 mcg daily vs placebo
Placebo
Placebo
Other: Placebo
Placebo



Primary Outcome Measures :
  1. Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps [ Time Frame: at study enpoints ]

Secondary Outcome Measures :
  1. glucose control [ Time Frame: at study endpoints ]
  2. body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans [ Time Frame: at study endpoints ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00398853


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: William Cefalu, MD Pennington Biomedical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Cefalu, MD, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00398853     History of Changes
Other Study ID Numbers: 1R01DK060126 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by William Cefalu, MD, Pennington Biomedical Research Center:
insulin
glucose
chromium

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Chromium
Picolinic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action