Diabetic nephropathy is a serious complication of diabetes mellitus, which is the leading cause of end-stage renal disease (ESRD). Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal experimental models. We investigate the effect of benfotiamine supplementation in patients with diabetic nephropathy, and hypothesize that it will slow down the progression to ESRD.
Conditions
Interventions
Trade Name: Milgamma mono 300
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
UMCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diabetes mellitus, with onset of disease after the age of 40 years • Age: 50-70 years • Patients are on treatment with angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin II antagonists (AIIA) in an unchanged dose for at least 3 months • Active diabetic nephropathy as indicated by presence of microalbuminuria (30-300 mg/24 h urine) in at least two samples within 2-6 weeks in advance of inclusion in the trial • HbA1c 30 ml/min • Males and postmenopausal females • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Renal impairment by other causes than diabetes • Stage of the disease more severe than indicated in "Inclusion criteria" (macroalbuminuria or renal insufficiency) • Severe hypoglycemia during the last 3 months, needing help from another person • Severe hepatopathy (liver function enzymes about three times higher than normal) • Endocrine disorders, e.g. hyper-/hypothyroidism • Blood pressure > 160/90 mmHg • Severe cardiac function disturbances and severe heart rhythm disturbances • Neoplasm • Severe general diseases or mental disorders making the participation in the study impossible • Drug abuse • Female patients during pregnancy and lactation period and female patients with active menses during the past year • Hypersensitivity to benfotiamine or other constituents of the study medication • HbA1c >9.5% • Use of vitamin B containing supplements during the last 3 months • Use of NSAIDs more than 3x per week (including self-medication) • Participation in another study within one month before joining the benfotiamine study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether short-term treatment (3 months) with benfotiamine leads to a reduction in urinary excretion of ß2-microglobulin and albumin.;Secondary Objective: To investigate whether short-term treatment (3 months) with benfotiamine leads to reduction in urinary excretion of markers of renal tubulointerstitial damage and inflammation (Kidney Injury Molecule-1, Monocyte Chemo-attractant Protein-1, Macrophage Inhibiting Factor, Complement factor C3d);Primary end point(s): Change in urinary excretion of (measured in 24-hour urine): • ß2-microglobulin • Albumin | — |
Countries
Netherlands
Outcome results
None listed