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

NCT06994871 | Enrolling By Invitation

• 1 other identifier: 2024-880-03
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Changes of intrahepatic triglyceride contents

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

  Baseline, 12 weeks

Secondary Outcomes (14)

• the proportions of MRI-PDFF response

  baseline, 12 weeks

• Changes of liver fibrosis

  Baseline, 12 weeks

• Changes of liver transaminase

  Baseline, 12 weeks

• Changes of liver fibrosis degree

  Baseline, 12 weeks

• Changes of FIB-4 index

  Baseline, 12 weeks

Other Outcomes (4)

• Incidence of Adverse Events

  From Baseline to Week 12

• Change of cardiac autonomic function

  Baseline, week 12

• Change of additional glucose related parameters

  baseline, Week 12

Study Arms (3)

Aerobic exercise

EXPERIMENTAL

The subjects receive aerobic exercise for 12 weeks.

Other: Aerobic exercise

Resistance exercise

EXPERIMENTAL

The subjects receive resistance exercise for 12 weeks.

Other: Resistance exercise

combined exercise

EXPERIMENTAL

The subjects receive both aerobic and resistance exercise for 12 weeks.

Other: combined exercise

Interventions

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.

Aerobic exercise

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.

Resistance exercise

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.

combined exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (2)

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

Nanjing, Jiangsu, 210008, China

Location

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

Nanjing, China

Location

MeSH Terms

Interventions

Exercise; Resistance Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Yan Bi, MD,PhD

  Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the exercise interventions, participants and exercise physiologists responsible for intervention delivery cannot be masked to group assignment. The trial will therefore use an open-label intervention design with masked outcome assessment and masked statistical analysis. Intervention delivery and outcome assessment will be performed by separate study teams. Exercise physiologists may collect intervention-related information, including attendance, exercise dose, adherence, protocol deviations, and safety events, but will not perform the prespecified primary or secondary outcome assessments. Baseline assessments will be completed before group allocation. Postintervention outcome assessments will be performed by trained assessors who are independent of the intervention team and masked to group assignment. Participants will be instructed not to disclose their assigned intervention to outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: May 29, 2025
• Study Start: March 9, 2025
• Primary Completion: September 10, 2026
• Study Completion: September 17, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)