Effects of Vitamin B1 in Type 1 Diabetic Patients - Full Text View

Sponsors and Collaborators:	University Hospital, Aker The Research Council of Norway
Information provided by:	University Hospital, Aker
ClinicalTrials.gov Identifier:	NCT00117026

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: Benfotiamine	Phase I Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Thiamine 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m- ethylthiazolium chloride, monohydrochloride Benfotiamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?

Further study details as provided by University Hospital, Aker:

Primary Outcome Measures:

Lower-limb nerve conduction velocity

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2009

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

Study ID Numbers:	AkerU
Study First Received:	June 30, 2005
Last Updated:	June 29, 2007
ClinicalTrials.gov Identifier:	NCT00117026
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by University Hospital, Aker:

Diabetes Complications
benfotiamine
type 1 diabetes

elevated urinary albumin excretion
nerve function
advanced glycation end products

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Benphothiamine
Diabetes Mellitus, Type 1
Thiamine
Disease Progression

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Adjuvants, Immunologic
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009