kidney protein leakage in diabetes Microalbuminuria in diabetes type 2
Conditions
Interventions
During 3 months, participants will take a placebo or a Food for Special Medical
Purposes (FSMP) containing 200 mg of monomeric and oligomeric flavanols daily.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Diagnosed diabetes mellitus type 2 • Age 40-85 • Micro albuminuria (>=20 *g albumin/min in 24h urine or albumin/creatinine ratio of >=2,5 (male) or >=3,5 (female) in urine portion) measured in the last 6 months
Exclusion criteria
Exclusion criteria: • Prior or current use of the Investigational Product and/or similar products (dietary supplements and/or FSMP*s) (to avoid de-blinding) • Use of anticoagulants • History of any organ transplantation • Albuminuria due to other causes, such as systemic lupus erythematodes (SLE) or sarcoidosis • Pregnancy or lactation during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in microalbuminuria between baseline and 3 months, measured as Albumin Excretion Rate (AER) in 24h urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers for endothelial function and progression of nephropathie: - asymmetric dimethylarginine (ADMA) - vascular cell adhesion molecule 1 (VCAM-1) - intercellular cell adhesion molecule 1 (ICAM-1) - interleukin 6 (IL-6) - von Willebrand Factor (vWF) | — |
Countries
Netherlands
Outcome results
None listed