Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06994871

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

A study testing Aerobic exercise, Resistance exercise and combined exercise in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Metabolic Dysfunction-Associated Steatotic Liver Disease
What is being tested?: Aerobic exercise, Resistance exercise and combined exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 2 sitesChina
Study dates: 9 Mar 2025to 17 Sep 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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%).

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing

Other trials in China

About this study

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

Read the 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.

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Being tested: Aerobic exercise, Resistance exercise, combined exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aerobic exerciseOther
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 exerciseOther
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 exerciseOther
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.

Study groups in NCT06994871
Study group	Role	What they receive
Aerobic exercise	Experimental	The subjects receive aerobic exercise for 12 weeks. Receives: Other: Aerobic exercise
Resistance exercise	Experimental	The subjects receive resistance exercise for 12 weeks. Receives: Other: Resistance exercise
combined exercise	Experimental	The subjects receive both aerobic and resistance exercise for 12 weeks. Receives: Other: combined exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes of intrahepatic triglyceride contents
The changes of intrahepatic triglyceride contents were measured by MRI-PDFF.
Measured: Baseline, 12 weeks

Secondary outcomes (14)

the proportions of MRI-PDFF response
the proportions of participants achieving at least 30% and at least 50% relative reduction in MRI-PDFF and MRI-PDFF <5% at week 12
Measured: baseline, 12 weeks
Changes of liver fibrosis
The changes of liver fibrosis were measured by MRE.
Measured: Baseline, 12 weeks
Changes of liver transaminase
The changes of liver transaminase were measured by ALT, AST, γ-GGT, ALP.
Measured: Baseline, 12 weeks
Changes of liver fibrosis degree
The changes of liver fibrosis were measured by LSM.
Measured: Baseline, 12 weeks
Changes of FIB-4 index
The changes of liver fibrosis can be measured by FIB-4 index.
Measured: Baseline, 12 weeks
Changes of body weight
The changes of body weight were measured by InBody-770 equipment.
Measured: Baseline, 12 weeks
Changes of body fat
The changes of body fat were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.
Measured: Baseline, 12 weeks
Changes of muscle mass
The changes of muscle mass were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.
Measured: Baseline, 12 weeks
Changes of muscle function
The changes of muscle function were measured by strength test using athletic equipments.
Measured: Baseline, 12 weeks
Changes of HbA1c.
The changes of glucose metabolism indexes were measured by HbA1c.
Measured: Baseline, 12 weeks
Changes of blood glucose
The changes of glucose metabolism indexes were measured by blood glucose.
Measured: Baseline, 12 weeks
Changes of blood insulin
The changes of glucose metabolism indexes were measured by blood insulin.
Measured: Baseline, 12 weeks
Changes of lipid metabolism indexes
The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol.
Measured: Baseline, 12 weeks
Change of cardiorespiratory fitness
The change of cardiorespiratory fitness assessed using peak oxygen uptake
Measured: baseline, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202517 Sep 2026

First posted29 May 2025
Study start9 Mar 2025
Primary completion10 Sep 2026 (estimated)
Study completion17 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 186 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06994871
Sponsor's protocol ID: 2024-880-03
Status last verified: Sep 2026
First submitted: 5 Jan 2025
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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