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NCT Number: NCT06994871

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Other

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.

Resistance Exercise

Other

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.

Combined exercise

Other

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 outcomes

  1. Changes of intrahepatic triglyceride contents

    Time frame: Baseline, 12 weeks

    The changes of intrahepatic triglyceride contents were measured by MRI-PDFF.

Secondary outcomes

  1. Changes of liver transaminase

    Time frame: Baseline, 12 weeks

    The changes of liver transaminase were measured by ALT, AST, γ-GGT, ALP.

  2. Changes of liver fibrosis

    Time frame: Baseline, 12 weeks

    The changes of liver fibrosis were measured by MRE.

  3. Changes of liver fibrosis degree

    Time frame: Baseline, 12 weeks

    The changes of liver fibrosis were measured by LSM.

  4. Changes of FIB-4 index

    Time frame: Baseline, 12 weeks

    The changes of liver fibrosis can be measured by FIB-4 index.

  5. Changes of body weight

    Time frame: Baseline, 12 weeks

    The changes of body weight were measured by InBody-770 equipment.

  6. Changes of body fat

    Time frame: Baseline, 12 weeks

    The changes of body fat were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.

  7. Changes of muscle mass

    Time frame: Baseline, 12 weeks

    The changes of muscle mass were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.

  8. Changes of muscle function

    Time frame: Baseline, 12 weeks

    The changes of muscle function were measured by strength test using athletic equipments.

  9. Changes of HbA1c.

    Time frame: Baseline, 12 weeks

    The changes of glucose metabolism indexes were measured by HbA1c.

  10. Changes of blood glucose

    Time frame: Baseline, 12 weeks

    The changes of glucose metabolism indexes were measured by blood glucose.

  11. Changes of blood insulin

    Time frame: Baseline, 12 weeks

    The changes of glucose metabolism indexes were measured by blood insulin.

  12. Changes of lipid metabolism indexes

    Time frame: Baseline, 12 weeks

    The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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