Status:
NOT_YET_RECRUITING
Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead Sponsor:
Shanghai East Hospital
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients.
Eligibility Criteria
Inclusion
- Meeting the diagnostic criteria for MASLD.
- Aged between 18 and 70 years (inclusive), regardless of gender.
- Patients voluntarily participate in this clinical study, have signed the informed consent form, and agree to comply with all study requirements, including follow-up visits, examinations, and treatments.
Exclusion
- Exclusion of other conditions causing liver injury, including alcoholic hepatitis, active hepatitis B or C virus infection, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, Wilson's disease, α1-antitrypsin deficiency, liver cancer (or family history of liver cancer), etc.
- History of medication use for more than 2 weeks within the past year that may induce hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen exceeding hormone replacement doses, anabolic steroids, valproic acid, or other known hepatotoxins).
- Use of hepatoprotective drugs (including but not limited to reduced glutathione, glucurolactone, glycyrrhizin preparations, nicotinamide, bifendate, liver-protecting tablets, silymarin, polyene phosphatidylcholine, S-adenosylmethionine, ursodeoxycholic acid, vitamin E, or other herbal medicines affecting liver function) within 4 weeks prior to enrollment.
- Presence of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or history of liver transplantation at randomization or previously, or planned liver transplantation.
- Concurrent type 1 diabetes.
- Severe cardiovascular, cerebrovascular, renal, or hematopoietic system diseases, as well as mood disorders (e.g., anxiety, depression) or psychiatric illnesses.
- Patients with any type of malignancy or a history of malignancy.
- HIV-positive status.
- Pregnant or breastfeeding women, or subjects of childbearing potential unwilling or unable to use effective contraception from the screening period until 6 months after discontinuation of the investigational drug.
- Participation in other interventional clinical trials within 12 weeks prior to screening.
- Patients with unstable weight (i.e., weight loss or gain exceeding 4 kg in the past 3 months) or those with conditions preventing participation in the exercise program.
- Other conditions deemed by the investigator as unsuitable for participation in this study.
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2028
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06994234
Start Date
June 20 2025
End Date
June 20 2028
Last Update
May 29 2025
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120