Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of liver stiffness
研究概览
简要总结
The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) works to treat Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD). The main questions it aims to answer are:
Does HBOT decreases the fat content and fibrosis state of liver in adult MASLD patients? Does HBOT improves the liver function and metabolic condition in adult MASLD patients?
Participants will:
Receive HBOT for 20 times in 1 month or recerive regular drug; Visit the clinic for checkups and tests at the starting, ending of the therapy and 6 month after the therapy.
详细描述
Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) patients who meet our principles would be randomized into 2 groups: the HBOT group and CON group. The entire project is not blinded. In HBOT group, participants will receive HBOT for 20 times in 1 month (2.0ATA, 60min), which is the common setting in clinical use.The CON group, which means the control group, recerives regular drug, like liver-protective drugs and hypoglycemic drugs. The visiting times are week 0 (starting of the project), week 4 (ending of the therapy), week 28 (6 months after the therapy), when participants get checkups and tests. The primary outcome of our study are the change of liver fat content and stiffness in Fibroscan. The secondary outcomes invovle changes of liver function enzymes and metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic dysfunction-associated steatotic liver disease patients
排除标准
- •Participants are unfit for hyperbaric treatment.
- •Participants with prior oxygen therapy within the last 6 months.
- •Participants with history of viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency.
- •Participants with severe organ dysfunctions or malignant tumors.
- •Participants have weight loss plan or major operations within the last 6 months.
- •Participants are unable to provide informed consent or currently participating in or has within the last 3 months participated in any other clinical trial.
- •Participants are pregnant or lactating.
- •Participants with claustrophobia or that cannot decompress properly.
结局指标
主要结局
Change of liver stiffness
时间窗: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
We use E value to describe liver stiffness by Fibroscan noninvasive transient elastography.
Change of liver fat content
时间窗: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
We use controlled attenuation parameter (CAP) to evaluate liver fat content by Fibroscan noninvasive transient elastography.
次要结局
- Change of liver enzymes(Before the 1-month treatment, directly after the treatment, 6 months after the treatment)
- Change of fasting blood glugose(Before the 1-month treatment, directly after the treatment, 6 months after the treatment)
- change of total triglyceride(Before the 1-month treatment, directly after the treatment, 6 months after the treatment)
- Change of fasting insulin(Before the 1-month treatment, directly after the treatment, 6 months after the treatment)
- Change of cholesterol(Before the 1-month treatment, directly after the treatment, 6 months after the treatment)
研究者
Lu Chen
MS
Jinling Hospital, China