Trial record 18 of 98 for:    CHROMIUM

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

This study has been completed.
Sponsor:
Collaborator:
Pharma Nord
Information provided by:
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00145093
First received: September 2, 2005
Last updated: November 21, 2005
Last verified: September 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00145093     History of Changes
Other Study ID Numbers: 04.0536P
Study First Received: September 2, 2005
Last Updated: November 21, 2005
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

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

ClinicalTrials.gov processed this record on July 31, 2014