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Completed

NCT Number: NCT00117026

Effects of Vitamin B1 in Type 1 Diabetic Patients

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aker University Hospital

Oslo, 0514, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo for benfotiamine

Benfotiamine

Drug

300mg/day

Other names: S-benzoylthiamine O-monophoshate

Primary outcomes

  1. Lower-limb nerve conduction velocity

    Time frame: 24 months

Secondary outcomes

  1. Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Aker

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Jul 4, 2005
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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