NCT00565318

Benfotiamine in Diabetic Nephropathy

A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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. Intervention: 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

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Benfotiamine	3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
DRUG	Placebo	3x 1 film coated tablet daily. Duration: 12 weeks.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-11-29
• Last updated: 2009-11-16

Locations

1 site across 1 country: Netherlands