Status:
COMPLETED
Effects of Vitamin B1 in Type 1 Diabetic Patients
Lead Sponsor:
University Hospital, Aker
Collaborating Sponsors:
The Research Council of Norway
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 m...
Eligibility Criteria
Inclusion
- Type 1 diabetes (of at least 15 years duration) as assessed by medical history.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00117026
Start Date
August 1 2005
End Date
February 1 2011
Last Update
May 10 2013
Active Locations (1)
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1
Aker University Hospital
Oslo, Norway, 0514