Effects of Vitamin B1 in Type 1 Diabetic Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117026
• Other study ID #: AkerU
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 30, 2005
• Last updated: May 8, 2013
• Start date: August 2005
• Est. completion date: February 2011

Study information

• Verified date: May 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• Placebo
Placebo for benfotiamine
• Benfotiamine
300mg/day

Locations

Country	Name	City	State
Norway	Aker University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Aker	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower-limb nerve conduction velocity		24 months	No
Secondary	Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)		24 months	No