Effects of Vitamin B1 in Type 1 Diabetic Patients

May 8, 2013 updated by: Kristian F. Hanssen, University Hospital, Aker

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0514
        • Aker University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Benfotiamine
Benfotiamine 300mg/day
Drug: Benfotiamine
300mg/day
Other Names:
  • S-benzoylthiamine O-monophoshate
Placebo Comparator: Placebo
Placebo for benfotiamine
Drug: Placebo
Placebo for benfotiamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower-limb nerve conduction velocity
Time Frame: 24 months
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Aker

Collaborators

The Research Council of Norway

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 4, 2005

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkerU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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