跳至主要内容
临床试验/EUCTR2004-000799-15-NO
EUCTR2004-000799-15-NO进行中(未招募)不适用

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

Aker University Hospital0 个研究点开始时间: 2004年6月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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.

研究者

发起方
Aker University Hospital

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