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Effects of Vitamin B1 in Type 1 Diabetic Patients

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

Placebo

Benfotiamine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Complications, benfotiamine, type 1 diabetes, elevated urinary albumin excretion, nerve function, advanced glycation end products

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Aker University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Benfotiamine

Placebo

Arm Description

Benfotiamine 300mg/day

Placebo for benfotiamine

Outcomes

Primary Outcome Measures

Lower-limb nerve conduction velocity

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00117026

First Posted

June 30, 2005

Last Updated

May 8, 2013

Sponsor

University Hospital, Aker

Collaborators

The Research Council of Norway

1. Study Identification

Unique Protocol Identification Number

NCT00117026

Brief Title

Effects of Vitamin B1 in Type 1 Diabetic Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Aker

Collaborators

The Research Council of Norway

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Diabetes Complications, benfotiamine, type 1 diabetes, elevated urinary albumin excretion, nerve function, advanced glycation end products

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benfotiamine

Arm Type

Experimental

Arm Description

Benfotiamine 300mg/day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for benfotiamine

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for benfotiamine

Intervention Type

Drug

Intervention Name(s)

Benfotiamine

Other Intervention Name(s)

S-benzoylthiamine O-monophoshate

Intervention Description

300mg/day

Primary Outcome Measure Information:

Title

Lower-limb nerve conduction velocity

Time Frame

24 months

Secondary Outcome Measure Information:

Title

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

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristian F Hanssen, MD, PhD

Organizational Affiliation

University Hospital, Aker

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aker University Hospital

City

Oslo

ZIP/Postal Code

0514

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

22446172

Citation

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. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.

Results Reference

derived

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Effects of Vitamin B1 in Type 1 Diabetic Patients

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