Effects of Vitamin B1 in Type 1 Diabetic Patients
Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?
1 other identifier
interventional
67
1 country
1
Brief Summary
The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 4, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMay 10, 2013
May 1, 2013
4.8 years
June 30, 2005
May 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower-limb nerve conduction velocity
24 months
Secondary Outcomes (1)
Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)
24 months
Study Arms (2)
Benfotiamine
EXPERIMENTALBenfotiamine 300mg/day
Placebo
PLACEBO COMPARATORPlacebo for benfotiamine
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes (of at least 15 years duration) as assessed by medical history.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Akerlead
- The Research Council of Norwaycollaborator
Study Sites (1)
Aker University Hospital
Oslo, 0514, Norway
Related Publications (1)
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.
PMID: 22446172DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristian F Hanssen, MD, PhD
University Hospital, Aker
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 4, 2005
Study Start
August 1, 2005
Primary Completion
June 1, 2010
Study Completion
February 1, 2011
Last Updated
May 10, 2013
Record last verified: 2013-05