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

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Benfotiamine	Phase I Phase II

Further Study Details: 

Primary Outcomes: Overnight urinary albumin excretion
Secondary Outcomes: Lower limb nerve function; Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1); Erythrocyte transketolase activity
Expected Total Enrollment:  80

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Type 1 diabetes (of at least 10 years duration) as assessed by medical history.
• Micro/macroalbuminuria (urinary albumin excretion > 15 ug/min in two out of three overnight urine samples)

Exclusion Criteria:

• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00117026

Kristian F Hanssen, MD, PhD      +4722894976    k.f.hanssen@medisin.uio.no
David A Fraser, PhD      +4723033430    d.a.fraser@medisin.uio.no

Norway
      Aker University Hospital, Oslo,  0514,  Norway

Study chairs or principal investigators

Kristian F Hanssen, MD, PhD,  Principal Investigator,  Aker University Hospital   

Study ID Numbers:  AkerU
Record last reviewed:  June 2005
Last Updated:  July 1, 2005
Record first received:  July 1, 2005
ClinicalTrials.gov Identifier:  NCT00117026
Health Authority: Norway: Norwegian Medicines Agency
ClinicalTrials.gov processed this record on 2005-07-05