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

History of Changes

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: B Vitamins Diabetes Diabetes Type 1

Drug Information available for: Thiamine

U.S. FDA Resources

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

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):

Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. Epub 2012 Mar 23.

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 May 23, 2013

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