Chromium and Insulin Action

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ClinicalTrials.gov Identifier: NCT00283777

Recruitment Status : Completed

First Posted : January 30, 2006

Last Update Posted : April 8, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

William Cefalu, MD, Pennington Biomedical Research Center

Tracking Information

First Submitted Date ^ICMJE

January 26, 2006

First Posted Date ^ICMJE

January 30, 2006

Last Update Posted Date

April 8, 2016

Study Start Date ^ICMJE

August 1998

Actual Primary Completion Date

January 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Insulin Senstivity, glycated hemoglobin

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

weight, body composition

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chromium and Insulin Action

Official Title ^ICMJE

Effect of Chromium Picolinate on Metabolic and Physiologic Parameters in Type 2 Diabetes

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 on blood glucose levels and insulin sensitivity

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Chromium Picolinate

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

April 2003

Actual Primary Completion Date

January 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Significant cardiovascular, hepatic or renal disease

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

25 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00283777

Other Study ID Numbers ^ICMJE

PBRC 23041

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

William Cefalu, MD, Pennington Biomedical Research Center

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Pennington Biomedical Research Center

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William Cefalu, MD

University of Vermont and Pennington Biomedical Research Center

PRS Account

Pennington Biomedical Research Center

Verification Date

April 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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