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Chromium Effects in Impaired Glucose Tolerance

This study is not yet open for patient recruitment.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to investigate the effects of Chromium on glucose tolerance in adults with impaired glucose tolerance (IGT).

Condition Treatment or Intervention Phase
Obesity
 Drug: Chromium
Phase II

MedlinePlus related topics:  Obesity

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Further Study Details: 

Expected Total Enrollment:  60

Impaired glucose tolerance (IGT) is often a prelude to type II diabetes mellitus (DM) and its sequelae, and is a cardiac risk factor in its own right. The worsening epidemic of DM in the US, along with the increasing prevalence of obesity, insulin resistance, and IGT, render the identification of promising interventions for these states a matter of some urgency. While lifestyle interventions based on dietary pattern and physical activity can delay or prevent the onset of diabetes, and reduce cardiovascular risk, adherence at the population level is severely limiting. Pharmacotherapy offers promise for diabetes prevention, but with associated high costs, unacceptability to many patients, and potential toxicity. In this context, the potential role of chromium (Cr), an insulin co-factor, in IGT is of great interest. Chromium use is widespread, but evidence of any therapeutic effect is limited.

Participants in this study will receive daily doses of either Cr or placebo for 6 months. The Cr will be given at two dose levels. The effects of Cr on serum measures of glucose tolerance and on brachial artery endothelial function will be measured. The study is powered to detect a clinically meaningful effect of Cr supplementation at either dose on glucose control, and to compare the two doses for equivalence. The study will generate much needed data regarding the efficacy of Cr in IGT and offers the promise of guiding practice, as well as directing future study. By contributing to knowledge related to potential diabetes prevention strategies, this study addresses one of the more pressing public health issues in the US today.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location Information

Michelle LaRovera      203-732-1265    michelle.larovera@yalegriffinprc.org

Connecticut
      The Yale-Griffin Prevention Research Center, Derby,  Connecticut,  06418,  United States
Michelle LaRovera  203-732-1265    michelle.larovera@yalegriffinprc.org 
David L Katz, MD. MPH,  Principal Investigator

Study chairs or principal investigators

David L Katz, MD, MPH,  Study Director,  Yale University/Yale Prevention Research Center   

More Information

Study ID Numbers:  R21 AT001332-01A1
Record last reviewed:  October 2004
Record first received:  August 25, 2003
ClinicalTrials.gov Identifier:  NCT00067626
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20
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