Metabolic Dysfunction-associated Steatotic Liver DiseaseMASLDNCT06619808
Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases
A study testing Hyperbaric oxygen therapy in people with Metabolic Dysfunction-associated Steatotic Liver Disease and Hepatic Steatosis, run by Jinling Hospital, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease, Hepatic Steatosis, Non-alcoholic Fatty Liver Diseases
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic dysfunction-associated steatotic liver disease patients
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Miaofang Yang, MD contact
China1 site, 1 recruiting
- Recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210000
Lu Chen, 18690113660, 522023350160@smail.nju.edu.cn
About this study
Official title: Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Metabolic Dysfunction-associated Steatotic Liver Disease, Hepatic Steatosis, Non-alcoholic Fatty Liver Diseases
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- Metabolic Dysfunction-associated Steatotic Liver Disease, Hyperbaric Oxygen Therapy, Non-alcoholic Fatty Liver Diseases, Oxygen Therapy
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyProcedure or surgery
Participants receive 20 session of hyperbaric oxygen therapy (HBOT) in one month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Participants receive 20 session of hyperbaric oxygen therapy (HBOT) in 1 month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes). Receives: Procedure: Hyperbaric oxygen therapy |
| Symptomatic Treatment | No intervention | Participants receive basic symptomatic treatments like antidiabetic drug, antihypertensive drug, and hepatic protector. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of liver stiffness
We use E value to describe liver stiffness by Fibroscan noninvasive transient elastography.
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of liver fat content
We use controlled attenuation parameter (CAP) to evaluate liver fat content by Fibroscan noninvasive transient elastography.
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Secondary outcomes (5)
Change of liver enzymes
Alanine aminotransferase (ALT), aspertate aminotransferase(AST)
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of fasting blood glugose
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of fasting insulin
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of cholesterol
total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein(HDL-C)
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
change of total triglyceride
TG
Measured: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start29 Jul 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Chen, Jinling Hospital, China
- Investigators
- Miaofang Yang, MD, Study director, General Hospital of Eastern Theater Command, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619808
- Sponsor's protocol ID
- 2024DZKY-052-01
- Acronym
- MASLD
- Status last verified
- Sep 2024
- First submitted
- 11 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not suitable
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06619808
- Acronym / sponsor ID
- MASLD / 2024DZKY-052-01
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Procedure: Hyperbaric oxygen therapyParticipants receive 20 session of hyperbaric oxygen therapy (HBOT) in 1 month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes). |
| Symptomatic Treatment | No intervention | –Participants receive basic symptomatic treatments like antidiabetic drug, antihypertensive drug, and hepatic protector. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Metabolic dysfunction-associated steatotic liver disease patients
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyParticipants receive 20 session of hyperbaric oxygen therapy (HBOT) in one month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes). | Procedure or surgery | Hyperbaric Oxygen Therapy |
Primary outcome
Change of liver stiffness
Time frame: 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
Time frame: 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.
5 secondary outcomes
Change of liver enzymes
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of fasting blood glugose
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of fasting insulin
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of cholesterol
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
change of total triglyceride
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. Not suitable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miaofang Yang, MD contact
Miaofang Yang, MD study director
General Hospital of Eastern Theater Command, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy in people with Metabolic Dysfunction-associated Steatotic Liver Disease and Hepatic Steatosis, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Chen, MS (800-555-5555 ext. 86-18690113660, 522023350160@smail.nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of liver stiffness (time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.