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Toepassing van flavanolen in de dieetbehandeling van mensen met microalbuminurie bij diabetes type 2


- candidate number18295
- NTR NumberNTR4669
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2014
- Secondary IDsMEC-2014-426 METC Erasmus MC
- Public TitleToepassing van flavanolen in de dieetbehandeling van mensen met microalbuminurie bij diabetes type 2
- Scientific TitleUse of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes and microalbuminuria
- ACRONYMMOF-trial
- hypothesisWe hypothesize that monomeric and oligomeric flavanols (MOF) have a beneficial effect on renal-endothelial function in the dietary management of T2D, as reflected by improvement of AER and renal-endothelial biomarkers.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria• T2D
• Age 40-75 years
• Microalbuminuria (≥20 microg albumin/min in 24h urine or albumin/creatinine ratio of ≥2,5 (male) or ≥3,5 (female) in urine portion) measured during 6 months prior to the study
- Exclusion criteria• Prior or current use of the Investigational Product and/or similar products (dietary supplements and/or FSMP’s) providing above dietary average (25mg/day) amounts of MOF (to avoid de-blinding)
• Use of any coumarins
• History of any organ transplantation
• Albuminuria due to other causes, such as systemic lupus erythematodes (SLE) or sarcoidosis
• Pregnancy or lactation during the trial
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate31-dec-2018
- Target number of participants96
- InterventionsDuring 3 consecutive months, the intervention group receives 200 mg of MOF once daily in the form of a commercially available Food for Special Medical Purposes (Endoclair), whereas the control group receives a placebo once a day
- Primary outcomeRenal endothelial function will be measured before, during and after the intervention using albumin excretion rate in 24h urine (AER)
- Secondary outcomeEstablished plasma biomarkers for renal endothelial function, namely asymmetric dimethylarginine (ADMA), vascular cell adhesion molecule 1 (VCAM-1), interleukin 6 (IL-6), von Willebrand Factor (vWF) and intercellular cell adhesion molecule 1 (ICAM-1).
- Timepointsbaseline - 6 weeks - 3 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Kirsten Berk
- CONTACT for SCIENTIFIC QUERIES Kirsten Berk
- Sponsor/Initiator Erasmus Medical Center, Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
International Nutrition Company BV (INC BV, Loosdrecht, The Netherlands)
- Publications
- Brief summary
- Main changes (audit trail)Adjustments 8-jul-2018 MT:
NEW INCLUSION CRITERIA:
• T2D
• Age 40-85 years
• Microalbuminuria in the previous 6 months (as microalbuminuria can change during time, results shouldn’t be older than 6 months), defined as:
- 30-300 mg albumin in a 24-hour urine sample
- or 3.5-35 mg albumin/mmol creatinine in females and 2.5-25 mg albumin/mmol creatinine in males in a urine portion.
This definition is derived from the Dutch national guidelines.

NEW EXCLUSION CRITERIA
• Other types of diabetes mellitus as derived from the medical records
• Prior (less than 4 weeks before participating) or current use of any specific dietary supplementary products providing daily amounts of MOF of 25 mg/day or higher
• Anticoagulation medication
• Major health conditions: organ transplantation, untreated cancer, current chemotherapy or radiotherapy, acute or chronic organ failure
• Microalbuminuria due to other conditions than T2D
• Pregnancy or lactation during the trial

MULTICENTER TRIAL: Erasmus Medical Center in Rotterdam, and the community hospitals: Havenziekenhuis, IJsselland Ziekenhuis and Ikazia Ziekenhuis as well as GP-clinic Stichting Gezond op Zuid in Rotterdam
- RECORD7-jul-2014 - 8-jul-2018


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