Clinical trial NCT06994871: Effects of Different Exercises on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
Official title: Effects of Aerobic or Resistance Exercise, or Both on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of intrahepatic triglyceride contents
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Changes of liver transaminase
timeFrame: Baseline, 12 weeks
measure: Changes of liver fibrosis
timeFrame: Baseline, 12 weeks
measure: Changes of liver fibrosis degree
timeFrame: Baseline, 12 weeks
measure: Changes of FIB-4 index
timeFrame: Baseline, 12 weeks
measure: Changes of body weight
timeFrame: Baseline, 12 weeks
measure: Changes of body fat
timeFrame: Baseline, 12 weeks
measure: Changes of muscle mass
timeFrame: Baseline, 12 weeks
measure: Changes of muscle function
timeFrame: Baseline, 12 weeks
measure: Changes of HbA1c.
timeFrame: Baseline, 12 weeks
measure: Changes of blood glucose
timeFrame: Baseline, 12 weeks
measure: Changes of blood insulin
timeFrame: Baseline, 12 weeks
measure: Changes of lipid metabolism indexes
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Study officials:
affiliation: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
name: Yan Bi, MD,PhD
role: STUDY_DIRECTOR
References: