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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145093
First Posted: September 5, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pharma Nord
Information provided by:
Medical Research Foundation, The Netherlands
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145093


Locations
Netherlands
General Practice
Heerde, Netherlands
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

ClinicalTrials.gov Identifier: NCT00145093     History of Changes
Other Study ID Numbers: 04.0536P
First Submitted: September 2, 2005
First Posted: September 5, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Medical Research Foundation, The Netherlands:
Diabetes Mellitus, Type 2
Chromium
Saccharomyces cerevisiae

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Chromium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs