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临床试验/EUCTR2018-001663-22-NL
EUCTR2018-001663-22-NL进行中(未招募)1 期

Effects of ciprofibrate on myocardial insulin sensitivity in pre-diabetes - Ciprofibrate and pre-diabetes

Maastricht University0 个研究点目标入组 12 人开始时间: 2018年8月16日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
12

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

  • Age: 40-70 years
  • BMI: 27-35 kg/m2
  • Stable dietary habits: no weight gain or loss > 5kg in the last three months
  • Insulin resistant: glucose clearance rate below < 360 ml/kg/min, as determined using OGIS120
  • 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 12
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 12

排除标准

  • Patients with a cardiac disease or with instable angina
  • Haemoglobin <7.8 mmol/l
  • In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor
  • HbA1c > 6.5%
  • Diagnosed with type 1 or type 2 diabetes mellitus
  • Use of a fibrate
  • Medication use known to interfere with glucose homeostasis/metabolism
  • Use of anti-coagulants, excluding platelet aggregation inhibitors
  • Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
  • Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
  • Participation in another biomedical study within 1 month before the first screening visit
  • Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
  • Any contra-indication to MRI scanning.
  • Participation in earlier research or medical examinations in the past 3 months that included PET/MRI scanning

研究者

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