Effects of Chromium Supplementation on Parameters of the Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus

This study has been completed.

Sponsors and Collaborators:	Medical Research Foundation, The Netherlands Pharma Nord
Information provided by:	Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:	NCT00145093

Purpose

The purpose of this study is to determine whether chromium (yeast), is effective in improving glycaemic control and insulin resistance.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Baker’s yeast (Bio Chromium)	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Chromium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Organic Chromium Supplementation on Clinical Parameters of the Metabolic Syndrome, in Patients With Type 2 Diabetes Mellitus. A Randomised, Double-Blind, Placebo-Controlled Trial

Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:

To determine the effect of Baker’s yeast treatment on glycemicic control and insulin resistance when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus

Secondary Outcome Measures:

To determine the effect of Baker’s yeast treatment on serum lipids, blood pressure, body fat percentage and BMI when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus

Estimated Enrollment:	60
Study Start Date:	August 2004
Estimated Study Completion Date:	February 2005

Eligibility

Criteria

Inclusion Criteria:

type 2 diabetes with haemoglobin A1c level between 7 and 8.5% at the last visit
treated with oral blood glucose lowering therapy, which has not been changed for the last three months.

Exclusion Criteria:

pregnant women; women trying to become pregnant
patients with a serum creatinine concentration over 150 micromol/l in men and 120 micromol/l in women, Cockcroft < 50 ml/min
hepatic enzyme levels (ALAT) over 90 U/l (2 x upper limit)
patients known with allergy or intolerance for yeast
patients currently taking chromium supplements
patients treated with insulin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145093

Locations

Sponsors and Collaborators

Medical Research Foundation, The Netherlands

Pharma Nord

Investigators

Principal Investigator:

Henk JG Bilo, MD PhD FRCP

Isala clinics, medical research foundation

More Information

Study ID Numbers:	04.0536P
Study First Received:	September 2, 2005
Last Updated:	November 21, 2005
ClinicalTrials.gov Identifier:	NCT00145093
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:

Diabetes Mellitus, Type 2
Chromium
Saccharomyces cerevisiae

Study placed in the following topic categories:

Metabolic Diseases
Chromium
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009