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ISRCTN
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ISRCTN36704940
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ClinicalTrials.gov identifier
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Public title
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Metabolic effects of Diabecinn (oral cinnamon extract) in diabetes type 2, a placebo-controlled randomized clinical trial
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Scientific title
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Acronym
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Diabecinn trial
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Serial number at source
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N/A
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Study hypothesis
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The main objective of this randomized, placebo-controlled trial is to determine the effects of cinnamon extract on HbA1c and lipid profiles in type 2 diabetic patients.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised placebo-controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Diabetes Mellitus type 2 (DM type II)
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Participants - inclusion criteria
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1. Type 2 diabetes patients
2. Age 35-70 years inclusive
3. HbA1c between 7 and 12% inclusive
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Participants - exclusion criteria
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1. Pregnancy
2. Breast-feeding
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Anticipated start date
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01/05/2006
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Anticipated end date
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01/01/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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Diabecinn three times a day (tid) or placebo
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Primary outcome measure(s)
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HbA1c.
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Secondary outcome measure(s)
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1. Lipid profile
2. 6 point glucose profile
3. Hypoglycemia
4. Body weight
5. Free fatty acids
6. C-reactive protein (CRP)
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Sources of funding
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OTC Pharma
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Trial website
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Publications
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Contact name
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Dr
J.H.
DeVries
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Address
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Academic Medical Center
Department of Internal Medicine, F4-222
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 5669111
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Fax
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+31 (0)20 5669158
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Email
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j.h.devries@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC) (The Netherlands)
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Address
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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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28/04/2006
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Last edited
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28/04/2006
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Date ISRCTN assigned
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28/04/2006
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