Trial record 10 of 98 for:    CHROMIUM

Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00398853
First received: November 9, 2006
Last updated: January 25, 2010
Last verified: April 2009
  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

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps [ Time Frame: at study enpoints ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo
    chromium picolinate 1000 mcg daily vs placebo
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  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:
Chromium
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Picolinic acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014