Clinical trial NCT00117026: Effects of Vitamin B1 in Type 1 Diabetic Patients
Official title: Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Complications
benfotiamine
type 1 diabetes
elevated urinary albumin excretion
nerve function
advanced glycation end products
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2005-07-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower-limb nerve conduction velocity
timeFrame: 24 months
Secondary outcomes:
measure: Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)
timeFrame: 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Aker University Hospital
Study officials:
affiliation: University Hospital, Aker
name: Kristian F Hanssen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.