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临床试验/EUCTR2013-005075-40-FI
EUCTR2013-005075-40-FI进行中(未招募)不适用

The effect of Liraglutide treatment on postprandial chylomicron and VLDLkinetics, liver fat and de novo lipogenesis. A single-center randomizedcontrolled study. - LIRA

Research Programs' Unit, Diabetes & Obesity, University of Helsinki0 个研究点开始时间: 2014年2月3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

  • Obese subjects with T2D and a large waist (waist > 88 cm in women and > 92 cm in men, BMI 27–40 kg/m2, triglycerides between 1.0 – 4.0 mmol/L and LDL < 4.5 mmol/l) treated with a lifestyle or metformin (any dose) (HbA1c 6.5-9% ) and aged 30 – 75 years will be included. Subjects may or may not use statins
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6

排除标准

  • ?Type 1 diabetes
  • ?Apo E2/2 phenotype
  • ?ALT/AST > 3x ULN
  • ?GFR < 60 ml/min, clinically significant TSH outside normal range
  • ?Lipid-lowering drugs other than statins within 6 months
  • ?Treatment with pioglitazone, insulin, sulphonylureas, gliptines, glinides, SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day) within 6 months
  • ?Blood pressure > 160 mmHg systolic and/or > 105 diastolic
  • ?History of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism
  • ?Any medical condition that puts the patient in the risk of dehydration
  • ?Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
  • ?Females of childbearing potential who are not using adequate contraceptive methods
  • ?Subjects who have experienced side-effects previously from GLP-1 agonists
  • ?Non-compliance or withdrawal of consent

研究者

发起方
Research Programs' Unit, Diabetes & Obesity, University of Helsinki

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