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Home > "C" Clinical Trials Conditions > Chromium Effects in Impaired Glucose Tolerance  Chromium Effects in Impaired Glucose Tolerance
Chromium Effects in Impaired Glucose Tolerance
For Condition: Obesity
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this study is to investigate the effects of Chromium on glucose tolerance in adults with impaired glucose tolerance (IGT).
Details: 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:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Impaired Glucose tolerance (Plasma glucose 2 hours after 75g glucose is at least 140mg/dl but below 200mg/dl [7.8 mmol/l to 11.1 mmol/l] and Fasting plasma glucose is <126 mg/dl [7.0 mmol/l) - Connecticut residents willing to travel to Griffin Hospital in Derby, CT Exclusion Criteria: - Diabetes (fasting blood glucose > 126/mg/dl, 2 hour 75g OGTT plasma glucose > 200 mg/dl) - Hospitalization for heart disease in last 6 months - Impaired renal function: [creatinine clearance < 80ml/min., urinary albumin excretion >300mcg/mg CR] - Pancreatitis, Inflammatory bowel disease - Recent or significant abdominal surgery - Pregnancy - Polycystic ovarian syndrome or irregular menses - Multi-vitamins containing chromium - Drugs that affect insulin sensitivity, antihypertensive drugs, lipid lowering agents, glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
DavidKatz, Study Director, Yale University/Yale Prevention Research Center
The Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418
United States
Hilary Alonzo 203-732-1265
Additional Information:
Study ID Numbers: R21 AT001332-01A1;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067626
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Chromium Effects in Impaired Glucose Tolerance
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