Effects of Different Exercises on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic exercise, Resistance exercise, combined exercise.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Aerobic exercise
Intensity of exercise：Subjects conduct an aerobic exercise at 40-59% heart rate reserve(HRR). Time of aerobic exercise：from 30 to 45 minutes each day, five days a week. - Other Resistance exercise
The resistance exercise was consisted of equipment trainings and body weight trainings. Participants are required to exercise 3 times a week. Intensity of equipment trainings: 70% 1-RM. Exercise volume: 15-20 repetitions for a set, from 2 sets to 4 sets gradually. Body weight trainings: 15-30 repetitions for a set, from 2 sets to 4 sets gradually. - Other combined exercise
Subjects conduct both aerobic and resistance trainings. Details of aerobic training session: Subjects conduct an aerobic exercise at 40-59% heart rate reserve(HRR) from 50-55 minutes each day, 3-4 days a week. Details of resistance training session: The resistance exercise was consisted of equipment trainings and body weight trainings. Participants are required to exercise 2 times a week.
Primary outcome measures
- Changes of intrahepatic triglyceride contents [Time frame: Baseline, 12 weeks]
Secondary outcome measures (12)
- Changes of liver transaminase [Time frame: Baseline, 12 weeks]
- Changes of liver fibrosis [Time frame: Baseline, 12 weeks]
- Changes of liver fibrosis degree [Time frame: Baseline, 12 weeks]
- Changes of FIB-4 index [Time frame: Baseline, 12 weeks]
- Changes of body weight [Time frame: Baseline, 12 weeks]
- Changes of body fat [Time frame: Baseline, 12 weeks]
- Changes of muscle mass [Time frame: Baseline, 12 weeks]
- Changes of muscle function [Time frame: Baseline, 12 weeks]
- Changes of HbA1c. [Time frame: Baseline, 12 weeks]
- Changes of blood glucose [Time frame: Baseline, 12 weeks]
- Changes of blood insulin [Time frame: Baseline, 12 weeks]
- Changes of lipid metabolism indexes [Time frame: Baseline, 12 weeks]
Eligibility criteria
Inclusion criteria
- Metabolic dysfunction-associated steatotic liver disease pantients with high willingness and compliance;
- Age: 18-45 years old;
- BMI: 25-40kg/m2;
- Liver MRI-PDFF > 10%;
- Weight change <3% within 3 months before the intervention;
- Being sedentary (≤60 minutes/week of moderate intensity exercise)
- Without diabetes, or combined with type 2 diabetes (lifestyle control and glycated hemoglobin ≤7%).
Exclusion criteria
- 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.
- 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.
- Combined with other metabolic diseases: such as type 1 diabetes, hyperthyroidism, hypothyroidism, cushing syndrome, etc.
- Patients with cardiovascular disease: such as uncontrolled hypertension, acute coronary syndrome, myocardial infarction, severe arrhythmia requiring medical therapy, etc.
- Patients with cerebrovascular diseases: such as cerebral hemorrhage, ischemic stroke, etc.
- Patients with the history of biliary obstruction, neuromuscular disease, skeletal deformity, severe osteoporosis, chronic kidney disease, and malignancy.
- 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.
- Patients with the history of bariatric surgery, major surgery within 8 weeks before randomization, etc,
- Patients were enrolled in another clinical trial for the treatment of MASLD or weight loss within 1 year before randomization.
- Pregnancy, lactation period, or women who plan to pregnant within 6 months before randomization.
- Patients with mental healthy problems requiring medication.
- Inability or unwillingness to undergo magnetic resonance imaging, including claustrophobia, implantable cardioverter defibrillators, and pacemakers.
- Patients cannot complete 12-week exercise plan due to some reasons, such as frequent business trips.
- After assessment, patients are not suitable or unable to participate in this clinical trial due to personal reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medi — Nanjing
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medi — Nanjing
Identifiers
NCT: NCT06994871 · 2024-880-03