Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Complications, benfotiamine, type 1 diabetes, elevated urinary albumin excretion, nerve function, advanced glycation end products
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.
Interventions
DRUGPlacebo
Placebo for benfotiamine
DRUGBenfotiamine
300mg/day
Sponsors
The Research Council of Norway
University Hospital, Aker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower-limb nerve conduction velocity | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1) | 24 months |
Countries
Norway
Outcome results
None listed