Effects of Aerobic or Resistance Exercise, or Both on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Not Applicable

• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

• Registration Number: NCT06994871
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-01-05
• Study Start: 2025-03-09
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2026-03-25
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of intrahepatic triglyceride contents	Baseline, 12 weeks	The changes of intrahepatic triglyceride contents were measured by MRI-PDFF.

Secondary Outcome Measures

Name	Time	Method
Changes of liver transaminase	Baseline, 12 weeks	The changes of liver transaminase were measured by ALT, AST, γ-GGT, ALP.
Changes of liver fibrosis	Baseline, 12 weeks	The changes of liver fibrosis were measured by MRE, LSM, FIB-4.
Changes of body weight	Baseline, 12 weeks	The changes of body weight were measured by InBody-770 equipment.
Changes of body fat	Baseline, 12 weeks	The changes of body fat were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.
Changes of muscle mass	Baseline, 12 weeks	The changes of muscle mass were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.
Changes of muscle function	Baseline, 12 weeks	The changes of muscle function were measured by strength test using athletic equipments.
Changes of glucose metabolism indexes	Baseline, 12 weeks	The changes of glucose metabolism indexes were measured by HbA1c, insulin, blood glucose.
Changes of lipid metabolism indexes	Baseline, 12 weeks	The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol.

Trial Locations

Locations (1)

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, China