DOES BENFOTIAMINE SUPPLEMENTATION REDUCE SERUM LEVELS OF ADVANCED GLYCATION END PRODUCTS AND BIOCHEMICAL MARKERS OF VASCULAR DYSFUNCTION IN TYPE 1 DIABETES?

Conditions: Type 1 diabetes

Registration Number: EUCTR2004-000799-15-NO

Lead Sponsor: Aker University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO ASSESS WHETHER BENFOTIAMINE SUPPLEMENTATION REDUCES SERUM LEVELS OF ADVANCED GLYCATION END PRODUCTS AND BIOCHEMICAL MARKERS OF VASCULAR DYSFUNCTION IN PATIENTS WITH TYPE 1 DIABETES;Secondary Objective: TO ASSESS WHETHER BENFOTIAMINE SUPPLEMENTATION REDUCES URINARY ALBUMIN EXCRETION;Primary end point(s): AGEs: AGE, Ne-(carboxymethyl)lysine (CML), and hydroimidazolone (HI)<br>C-reactive protein (CRP), serum vascular cell adhesion molecule-1 (VCAM-1), interleukin (IL)-6.<br>

Secondary Outcome Measures