Effects of Different Exercises on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Nanjing University

Status: Invitation-only

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

Treatments: Other: Resistance exercise; Other: Aerobic exercise; Other: combined exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06994871

2024-880-03

Details and patient eligibility

About

This is a single-center, randomized, parallel controlled study to explore the effects of aerobic exercise, resistance exercise or aerobic combined resistance exercise on liver lipid in patients with MASLD, consisting of a 12-week core study followed by a 12-month extension phase.

Full description

This study was a single-center, randomized, parallel controlled clinical study. It conducted a 12-week exercise intervention for patients with MASLD, aiming to explore the effects of different exercise patterns for patients with MASLD. All subjects were randomly assigned to aerobic exercise, resistance exercise or aerobic combined resistance exercise groups. The liver lipid content was evaluated by MRI-PDFF values at baseline and 12 weeks after intervention. Liver function was evaluated by liver transaminase at baseline and 12 weeks after intervention. The degree of liver fibrosis was evaluated by MRE, LSM value and FIB-4 index at baseline and 12 weeks after intervention. The changes of body weight and body fat before and after the intervention were evaluated by Inbody-770, and the changes of muscle mass before and after the intervention were evaluated by DXA. The effects of different exercise methods on metabolic indexes were evaluated by the changes of blood glucose, glycated hemoglobin, insulin and blood lipid before and after the intervention. In addition, after the exercise intervention, this study plans to conduct a 12-month long-term follow-up.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Metabolic dysfunction-associated steatotic liver disease pantients with high willingness and compliance;
2. Age: 18-45 years old;
3. BMI: 25-40kg/m2;
4. Liver MRI-PDFF > 10%;
5. Weight change <3% within 3 months before the intervention;
6. Being sedentary (≤60 minutes/week of moderate intensity exercise)
7. Without diabetes, or combined with type 2 diabetes (lifestyle control and glycated hemoglobin ≤7%).

Exclusion criteria

1. Patients with a history of excessive alcohol consumption: Excessive alcohol consumption was defined as an average daily consumption of more than 20g of ethanol in women and 30g in men.
2. Other types of chronic liver disease: such as viral hepatitis, cirrhosis, liver cancer, autoimmune liver disease, Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, drug-induced liver disease, etc.
3. Combined with other metabolic diseases: such as type 1 diabetes, hyperthyroidism, hypothyroidism, cushing syndrome, etc.
4. Patients with cardiovascular disease: such as uncontrolled hypertension, acute coronary syndrome, myocardial infarction, severe arrhythmia requiring medical therapy, etc.
5. Patients with cerebrovascular diseases: such as cerebral hemorrhage, ischemic stroke, etc.
6. Patients with the history of biliary obstruction, neuromuscular disease, skeletal deformity, severe osteoporosis, chronic kidney disease, and malignancy.
7. Patients used drugs which may have potential effects on MASLD within 1 year before randomization, including PPAR agonist, SGLT2 inhibitor, GLP1 receptor agonist, insulin, etc.
8. Patients with the history of bariatric surgery, major surgery within 8 weeks before randomization, etc,
9. Patients were enrolled in another clinical trial for the treatment of MASLD or weight loss within 1 year before randomization.
10. Pregnancy, lactation period, or women who plan to pregnant within 6 months before randomization.
11. Patients with mental healthy problems requiring medication.
12. Inability or unwillingness to undergo magnetic resonance imaging, including claustrophobia, implantable cardioverter defibrillators, and pacemakers.
13. Patients cannot complete 12-week exercise plan due to some reasons, such as frequent business trips.
14. After assessment, patients are not suitable or unable to participate in this clinical trial due to personal reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 3 patient groups

Aerobic exercise

Experimental group

Description:

The subjects receive aerobic exercise for 12 weeks.

Treatment:

Other: Aerobic exercise

Resistance exercise

Experimental group

Description:

The subjects receive resistance exercise for 12 weeks.

Treatment:

Other: Resistance exercise

combined exercise

Experimental group

Description:

The subjects receive both aerobic and resistance exercise for 12 weeks.

Treatment:

Other: combined exercise