search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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- ISRCTNISRCTN no longer applicable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 trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-mrt-2016
- Target number of participants140
- 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)
- RECORD7-jul-2014 - 6-aug-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl