Effects of Vitamin B1 in Type 1 Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Kristian F. Hanssen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00117026
First received: June 30, 2005
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Placebo
Drug: Benfotiamine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Lower-limb nerve conduction velocity [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: August 2005
Study Completion Date: February 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Benfotiamine
Benfotiamine 300mg/day
Drug: Benfotiamine
300mg/day
Other Name: S-benzoylthiamine O-monophoshate
Placebo Comparator: Placebo
Placebo for benfotiamine
Drug: Placebo
Placebo for benfotiamine

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117026

Locations
Norway
Aker University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
University Hospital, Aker
The Research Council of Norway
Investigators
Principal Investigator: Kristian F Hanssen, MD, PhD University Hospital, Aker
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristian F. Hanssen, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00117026     History of Changes
Other Study ID Numbers: AkerU
Study First Received: June 30, 2005
Last Updated: May 8, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Diabetes Complications
benfotiamine
type 1 diabetes
elevated urinary albumin excretion
nerve function
advanced glycation end products

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Benphothiamine
Thiamine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014