EUCTR2016-002045-36-GB进行中（未招募）1 期
ifestyle induced weight loss and Liraglutide in the treatment of non-alcoholic steatohepatitis (NASH) - Lifestyle and Liraglutide in NASH
niversity of Oxford, Clinical Trials and Research Governance0 个研究点目标入组 50 人开始时间: 2019年2月5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）
- 发起方
- 入组人数
- 50
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
- •Non-diabetic (HbA1c <48mmol/mol)
- •BMI 25-40kg/m2
- •Age 18-75years
- •Diagnosis of NAFLD (hepatic steatosis on imaging or histology)
- •ALT = 1.5 ULN & <10 ULN on 2 occasions >7 days apart and or
- •Historical liver biopsy showing NASH and/or =F1 fibrosis or NFS = -1.455 OR Fib-4 = 1.3 OR Fibroscan =8kPa.
- •Non-pregnant, not planning pregnancy
- •BP<160/100mmHg – stable antihypertensive therapy for 6 months
- •No weight change >10% within the preceding 3 months
- •Normal renal function
- •No contraindications to Lifestyle or Liraglutide
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Age <18 or >75years
- •Body mass index <25 or >40kg/m2
- •A diagnosis of diabetes (type 1 or type 2)
- •Use of anti-diabetic or weight loss medications or a GLP-1 agonist such as Liraglutide)
- •Contra-indication to Liraglutide
- •A blood haemoglobin <120mg/dL
- •History of alcoholism or a greater than recommended alcohol intake (Recommendations > 21 drinks on average per week for men and > 14 drinks on average per week for women
- •Pregnant or nursing mothers
- •History of severe claustrophobia
- •Presence of metallic implants, pacemaker that are contra-indications to MRI scanning
- •Haemorrhagic disorders
- •Anticoagulant treatment
- •Other co-morbidities that in the eyes of the investigators may affect data collection
- •A medical condition in the opinion of the investigator that might impact upon safety or validity of the results
研究者
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