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临床试验/EUCTR2007-002815-20-GB
EUCTR2007-002815-20-GB进行中(未招募)不适用

A Prospective Randomised Pilot Study of Metformin and Lifestyle Intervention in the Prevention of Metabolic Syndrome due to Androgen Deprivation Therapy in Prostate Cancer - Metformin use in patients on ADT to prevent Metabolic Syndrome

Royal Surrey County Hospital0 个研究点开始时间: 2007年8月1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)

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
Male

入选标准

  • Male patients (all will be >18 in the study group)
  • Histologically confirmed adenocarcinoma of the prostate
  • Planned androgen deprivation therapy with LHRH analogue
  • Ability to give adequately informed consent to participate in study
  • WHO Performance status 0-1
  • 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) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Pre-existing Diabetes mellitus
  • Renal impairment - serum creatinine > 130 µmol/L, GFR < 40 mls/min
  • Cardiac failure
  • Respiratory failure
  • Myocardial infarction within 6 months
  • Hepatic impairment - LFTs >1.5x upper limit of normal
  • All of the above are contra-indications to metformin therapy.

研究者

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