EUCTR2020-004373-50-DK进行中（未招募）1 期
Effect of treatment with Semaglutide on cognitive function, neuroinflammation and hepatic nitrogen metabolism in patients with non-alcoholic steatohepatitis: A randomized placebo-controlled trial
Aarhus University Hospital0 个研究点目标入组 24 人开始时间: 2020年12月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •1. Age 18 - 69 years.
- •2. Biopsy-proven NASH
- •3. Understands and speaks Danish
- •4. Alcohol consumption < 40g/day
- •5. Exclusion of other liver pathology
- •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 4
排除标准
- •1. Known chronic inflammatory disease
- •2. Contraindication for liver biopsy: Anamnestic, clinical or laboratory signs of hemorrhagic diatesis, infection at the insertion area or focal changes in the liver
- •3. Diabetes Mellitus type 1 or 2 (HbA1c > 48 mmol/mol)
- •4. Bacterial infection
- •5. Known cancer
- •6. Known neurolodegenerative disease
- •7. Known severe impairment of hearing or eye sight
- •8. Known allergy towards one or more ingredients in the Ozempic® formula
- •9. Treatment with antipsychotics or other psychotropic drugs with sedative effects
- •10. Treatment with corticosteroids within the past 8 weeks
- •11. Breastfeeding
- •12. Pregnancy demonstrated by a positive pregnancy test or desire to become pregnant and no use of safe anti-conception (p-pills, intrauterine device, sterilised)
研究者
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