We 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.
Verkorte titel
Health condition
Diabetes type 2, microalbuminuria
Ondersteuning
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.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Renal endothelial function will be measured before, during and after the intervention using albumin excretion rate in 24h urine (AER)
Achtergrond van het onderzoek
-
Doel van het onderzoek
We 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.
Onderzoeksopzet
baseline - 6 weeks - 3 months
Onderzoeksproduct en/of interventie
During 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
Publiek
Kirsten Berk
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033055
k.berk@erasmusmc.nl
Wetenschappelijk
Kirsten Berk
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033055
k.berk@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
In dit register bekende (historische) registraties
Geen registraties gevonden
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4534 |
| NTR-old | NTR4669 |
| Ander register | METC Erasmus MC : MEC-2014-426 |