跳至主要内容
临床试验/EUCTR2012-005427-32-IT
EUCTR2012-005427-32-IT进行中(未招募)1 期

Randomized controlled trial of metformin and dietary restriction to prevent age-related morbid events in people with metabolic syndrome - MeMeMe

Fondazione IRCCS Istituto Nazionale dei Tumori0 个研究点目标入组 2,000 人开始时间: 2013年7月9日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
2,000

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

  • Age 55-74, waist circumference equal or greater than 85 cm for women and 100 cm for men, plus at least two other factors among those defining the metabolic syndrome.
  • 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 1000
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1000

排除标准

  • -Dignosed diabetes (or baseline fasting glycemia above 7 mmol/L) at baseline examination - cancer (except skin carcinoma) diagnosed in the last 5 years, or under treatment. -Excessive frailty: in absence of agreed-upon measurements parameters and cutoff points, we will exclude subjects under the lower 5th percentile of the muscular mass distribution estimated by impedance in previous studies. - Conditions that controindicate the use of MET because may favour lactic acidosis: Renal, cardiac, hepatic, or respiratory insufficiency, serum creatinine > 124 µmol/L, or proteinuria. Curent treatment with K-sparing diuretics, or with proton pump inhibitors. Excessive alcohol consumption. -Distressing side effects of MET treatment, such as nausea and diarrhoea.

研究者

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