Trial record 13 of 98 for:    CHROMIUM

Chromium and Insulin Action

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00283777
First received: January 26, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Insulin Senstivity, glycated hemoglobin

Secondary Outcome Measures:
  • weight, body composition

Estimated Enrollment: 30
Study Start Date: August 1998
Estimated Study Completion Date: April 2003
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 (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
Criteria

Inclusion Criteria:

Type 2 diabetes on diet therapy or low dose oral agent -

Exclusion Criteria:

Significant cardiovascular, hepatic or renal disease

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00283777

Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05410
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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:
Chromium
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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 July 29, 2014