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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00145093 |
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Date of registration:
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02/09/2005 |
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Primary sponsor: |
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Public title:
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Effects of Chromium Supplementation on Parameters of the Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus
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Scientific title:
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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 |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00145093 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Henk JG Bilo, MD PhD FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Isala clinics, medical research foundation |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Baker’s yeast (Bio Chromium)
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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