Effects of Vitamin B1 in Type 1 Diabetic Patients

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Placebo; Drug: Benfotiamine

• Registration Number: NCT00117026
• Lead Sponsor: University Hospital, Aker

Brief 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.

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-04
• Study Start: 2005-08
• Primary Completion: 2010-06
• Study Completion: 2011-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Type 1 diabetes (of at least 15 years duration) as assessed by medical history.

Exclusion Criteria

• Macroalbuminuria
• Symptomatic gastroparesis. Diabetic nephropathy with a creatinine clearance less than 60 cc/min.
• Evidence of chronic infection.
• History of any malignancy.
• Any chronic medical condition that unduly increases the risk for the potential enrollee as judged by study investigators.
• Pregnancy, breastfeeding or planned pregnancy within two years.
• Supplementation with thiamine > 2mg per day and/or alpha-lipoic acid
• Chronic alcoholism/alcohol abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for benfotiamine
Benfotiamine	Benfotiamine	Benfotiamine 300mg/day

Primary Outcome Measures

Name	Time	Method
Lower-limb nerve conduction velocity	24 months

Secondary Outcome Measures

Name	Time	Method
Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)	24 months

Trial Locations

Locations (1)

Aker University Hospital; 🇳🇴 Oslo, Norway