NCT00117026

Effects of Vitamin B1 in Type 1 Diabetic Patients

Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University Hospital, Aker · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.

Detailed description

Despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. It has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. However, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications. This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Placebo	Placebo for benfotiamine
DRUG	Benfotiamine	300mg/day

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-06-01
• Completion: 2011-02-01
• First posted: 2005-07-04
• Last updated: 2013-05-10

Locations

1 site across 1 country: Norway