Effects of Vitamin B1 in Type 1 Diabetic Patients

Sponsor

University Hospital, Aker (Other)

Overall Status

Completed

CT.gov ID

NCT00117026

Collaborator

The Research Council of Norway (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: Placebo Drug: Benfotiamine	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Benfotiamine Benfotiamine 300mg/day	Drug: Benfotiamine 300mg/day Other Names: S-benzoylthiamine O-monophoshate
Placebo Comparator: Placebo Placebo for benfotiamine	Drug: Placebo Placebo for benfotiamine

Arm

Intervention/Treatment

Experimental: Benfotiamine

Benfotiamine 300mg/day

Drug: Benfotiamine

300mg/day

Other Names:

S-benzoylthiamine O-monophoshate

Placebo Comparator: Placebo

Placebo for benfotiamine

Drug: Placebo

Placebo for benfotiamine

Outcome Measures

Primary Outcome Measures

Lower-limb nerve conduction velocity [24 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.