Effects of Vitamin B1 in Type 1 Diabetic Patients

Study Overview
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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.

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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Placebo
* Drug: Benfotiamine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benfotiamine<br>Benfotiamine 300mg/day | Drug: Benfotiamine<br>* 300mg/day<br>* Other names: S-benzoylthiamine O-monophoshate;|
| Placebo Comparator: Placebo<br>Placebo for benfotiamine | Drug: Placebo<br>* Placebo for benfotiamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower-limb nerve conduction velocity |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Complications, benfotiamine, type 1 diabetes, elevated urinary albumin excretion, nerve function, advanced glycation end products