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Effects of Vitamin B1 in Type 1 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117026
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : May 10, 2013
The Research Council of Norway
Information provided by (Responsible Party):
Kristian F. Hanssen, Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Placebo Drug: Benfotiamine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?
Study Start Date : August 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Benfotiamine
Benfotiamine 300mg/day
Drug: Benfotiamine
Other Name: S-benzoylthiamine O-monophoshate

Placebo Comparator: Placebo
Placebo for benfotiamine
Drug: Placebo
Placebo for benfotiamine

Primary Outcome Measures :
  1. Lower-limb nerve conduction velocity [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1) [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00117026

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Aker University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
University Hospital, Aker
The Research Council of Norway
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Principal Investigator: Kristian F Hanssen, MD, PhD University Hospital, Aker
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kristian F. Hanssen, Professor, Oslo University Hospital Identifier: NCT00117026    
Other Study ID Numbers: AkerU
First Posted: July 4, 2005    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013
Keywords provided by Kristian F. Hanssen, Oslo University Hospital:
Diabetes Complications
type 1 diabetes
elevated urinary albumin excretion
nerve function
advanced glycation end products
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action