Effects of Vitamin B1 in Type 1 Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-02-28

Brief Summary

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

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Detailed Description

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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

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Benfotiamine

Benfotiamine 300mg/day

Group Type EXPERIMENTAL

Benfotiamine

Intervention Type DRUG

300mg/day

Placebo

Placebo for benfotiamine

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for benfotiamine

Interventions

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Placebo

Placebo for benfotiamine

Intervention Type DRUG

Benfotiamine

300mg/day

Intervention Type DRUG

Other Intervention Names

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S-benzoylthiamine O-monophoshate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No