Benfotiamine in Diabetic Nephropathy
The purpose of this study is to investigate the effect of benfotiamine supplementation in patients with diabetic nephropathy, and to determine whether it will slow down the progression to end-stage renal disease (ESRD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy|
- Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in urinary excretion of: β2 microglobulin, macrophage inhibiting factor (MIF), monocyte chemo-attractant protein-1 (MCP-1), and other advanced glycation end-products (AGEs). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
|Placebo Comparator: B||
3x 1 film coated tablet daily. Duration: 12 weeks.
Other Name: Placebo, Wörwag Pharma GmbH & Co. KG
There is a worldwide increase in prevalence in type 2 diabetes mellitus, which is being paralleled by an increasing number of patients reaching dialysis because of diabetic nephropathy. Much of the fivefold increase in patients receiving dialysis treatment that occurred over the past two decades is attributable to type 2 diabetes and diabetic nephropathy. Diabetes is now the leading cause of end-stage renal disease (ESRD), with more than 40% of all new cases of ESRD occurring in patients with diabetes.
Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal experimental models. We hypothesize that benfothiamine supplementation in patients with diabetic nephropathy will ameliorate the effects of both albuminuria/proteinuria and hyperglycaemia on oxidative stress and advanced glycation end-products (AGEs) accumulation in renal tissue, and thereby decrease inflammatory responses and fibrotic responses, causing slowing down of progression to ESRD as a consequence.
The intervention duration is 12 weeks for each group.
- Group A: Benfotiamine (300 mg) 3x 1 film coated tablet daily (900 mg daily dose benfotiamine)
- Group B: Placebo 3x 1 film coated tablet daily
|Isala Klinieken Hospital|
|Zwolle, Netherlands, 8000 GK|
|Study Director:||G J Navis, MD, PhD||University Medical Centre Groningen|
|Principal Investigator:||H JG Bilo, MD, PhD||Isala Klinieken Hospital|