No registrations found.
ID
Source
Brief title
Health condition
Diabetes type 2, microalbuminuria
Sponsors and support
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.
Intervention
Outcome measures
Primary outcome
Renal endothelial function will be measured before, during and after the intervention using albumin excretion rate in 24h urine (AER)
Secondary outcome
Established 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).
Background summary
-
Study objective
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.
Study design
baseline - 6 weeks - 3 months
Intervention
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
Kirsten Berk
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033055
k.berk@erasmusmc.nl
Kirsten Berk
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033055
k.berk@erasmusmc.nl
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.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4534 |
| NTR-old | NTR4669 |
| Other | METC Erasmus MC : MEC-2014-426 |