EUCTR2004-000799-15-NOActive, not recruitingNot Applicable
DOES BENFOTIAMINE SUPPLEMENTATION REDUCE SERUM LEVELS OF ADVANCED GLYCATION END PRODUCTS AND BIOCHEMICAL MARKERS OF VASCULAR DYSFUNCTION IN TYPE 1 DIABETES?
Aker University Hospital0 sitesStarted: June 25, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Genders Eligible for Study: Both
- •Age 18 to 60 years, inclusive.
- •Type 1 diabetes mellitus for at least 5 years as defined by the following:
- •a. Insulin dependence
- •b. C-peptide < 160 nmol/l and/or anti-GAD positive.
- •In addition, microalbuminuria (urinary albumin excretion > 15 ug/min in two out of three overnight urine samples)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Symptomatic gastroparesis.
- •Urine albumin > 200 ug/min in timed overnight urine collection. 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 increase risk for the potential enrollee as judged by study investigators.
- •Pregnancy, breastfeeding or planned pregnancy within two years.
Investigators
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