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Sponsors and Collaborators: |
University Medical Centre Groningen Isala Klinieken Hospital Wörwag Pharma GmbH & Co. KG Predictions Network |
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Information provided by: | University Medical Centre Groningen |
ClinicalTrials.gov Identifier: | NCT00565318 |
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).
Condition | Intervention | Phase |
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Diabetic Nephropathy |
Drug: Benfotiamine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy |
Estimated Enrollment: | 86 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Benfotiamine
3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
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B: Placebo Comparator |
Drug: Placebo
3x 1 film coated tablet daily. Duration: 12 weeks.
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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.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alaa Alkhalaf, MD | 0031384247942 | a.alkhalaf@int.umcg.nl |
Contact: Stephan JL Bakker, MD, PhD | 0031503613677 | s.j.l.bakker@int.umcg.nl |
Netherlands | |
Isala Klinieken Hospital | Recruiting |
Zwolle, Netherlands, 8000 GK | |
Principal Investigator: H JG Bilo, MD, PhD |
Study Director: | G J Navis, MD, PhD | University Medical Centre Groningen |
Principal Investigator: | H JG Bilo, MD, PhD | Isala Klinieken Hospital |
Responsible Party: | University Medical Center Groningen ( Alaa Alkhalaf, M.D ) |
Study ID Numbers: | BENFO-1, NL17390.075.07 |
Study First Received: | November 28, 2007 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00565318 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Benfotiamine Diabetes Nephropathy |
Vitamin B Complex Diabetic Nephropathies Immunologic Factors Diabetes Mellitus Thiamine Adjuvants, Immunologic Endocrine System Diseases Trace Elements |
Urologic Diseases Benphothiamine Vitamins Micronutrients Kidney Diseases Endocrinopathy Chelating Agents Diabetes Complications |
Vitamin B Complex Diabetic Nephropathies Molecular Mechanisms of Pharmacological Action Immunologic Factors Growth Substances Physiological Effects of Drugs Diabetes Mellitus Thiamine Adjuvants, Immunologic |
Endocrine System Diseases Pharmacologic Actions Urologic Diseases Benphothiamine Vitamins Micronutrients Kidney Diseases Chelating Agents Diabetes Complications |