Clinical trial NCT06619808: Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases
Official title: Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Hepatic Steatosis
Non-alcoholic Fatty Liver Diseases
Keywords: Metabolic Dysfunction-associated Steatotic Liver Disease
Hyperbaric Oxygen Therapy
Non-alcoholic Fatty Liver Diseases
Oxygen Therapy
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Metabolic dysfunction-associated steatotic liver disease patients

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of liver stiffness
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
measure: Change of liver fat content
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Secondary outcomes:
measure: Change of liver enzymes
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
measure: Change of fasting blood glugose
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
measure: Change of fasting insulin
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
measure: Change of cholesterol
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
measure: change of total triglyceride
timeFrame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Other outcomes:
measure: Safety of hyperbaric oxygen therapy
timeFrame: After each session of HBOT and up to 6 months after the HBOT therapy.
Locations:
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
Study officials:
affiliation: General Hospital of Eastern Theater Command, China
name: Miaofang Yang, MD
role: STUDY_DIRECTOR
References: