Effects of Vitamin B1 in Type 1 Diabetic Patients

University Hospital, Aker

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Benfotiamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00117026

AkerU

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 2 patient groups, including a placebo group

Benfotiamine

Experimental group

Description:

Benfotiamine 300mg/day

Treatment:

Drug: Benfotiamine

Placebo

Placebo Comparator group

Description:

Placebo for benfotiamine

Treatment:

Drug: Placebo