Status:
COMPLETED
Effects of Chromium Supplementation on Parameters of the Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Medical Research Foundation, The Netherlands
Collaborating Sponsors:
Pharma Nord
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether chromium (yeast), is effective in improving glycaemic control and insulin resistance.
Detailed Description
Setting: Patients meeting the inclusion and not the exclusion criteria will be sent a letter containing information about the study and that they will be called within 2 weeks by one of the investiga...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00145093
Start Date
August 1 2004
End Date
February 1 2005
Last Update
November 22 2005
Active Locations (1)
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1
General Practice
Heerde, Netherlands