Metabolic Dysfunction-Associated Steatotic Liver Disease
Conditions
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.
Interventions
OTHERAerobic 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.
OTHERResistance 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.
OTHERcombined 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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of intrahepatic triglyceride contents | Baseline, 12 weeks | The changes of intrahepatic triglyceride contents were measured by MRI-PDFF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the proportions of MRI-PDFF response | baseline, 12 weeks | the proportions of participants achieving at least 30% and at least 50% relative reduction in MRI-PDFF and MRI-PDFF \<5% at week 12 |
| Changes of liver fibrosis | Baseline, 12 weeks | The changes of liver fibrosis were measured by MRE. |
| Changes of liver transaminase | Baseline, 12 weeks | The changes of liver transaminase were measured by ALT, AST, γ-GGT, ALP. |
| Changes of liver fibrosis degree | Baseline, 12 weeks | The changes of liver fibrosis were measured by LSM. |
| Changes of FIB-4 index | Baseline, 12 weeks | The changes of liver fibrosis can be measured by FIB-4 index. |
| Changes of body weight | Baseline, 12 weeks | The changes of body weight were measured by InBody-770 equipment. |
| Changes of body fat | Baseline, 12 weeks | The changes of body fat were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry. |
| Changes of muscle mass | Baseline, 12 weeks | The changes of muscle mass were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry. |
| Changes of muscle function | Baseline, 12 weeks | The changes of muscle function were measured by strength test using athletic equipments. |
| Changes of HbA1c. | Baseline, 12 weeks | The changes of glucose metabolism indexes were measured by HbA1c. |
| Changes of blood glucose | Baseline, 12 weeks | The changes of glucose metabolism indexes were measured by blood glucose. |
| Changes of blood insulin | Baseline, 12 weeks | The changes of glucose metabolism indexes were measured by blood insulin. |
| Changes of lipid metabolism indexes | Baseline, 12 weeks | The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol. |
| Change of cardiorespiratory fitness | baseline, week 12 | The change of cardiorespiratory fitness assessed using peak oxygen uptake |
Countries
China
Contacts
STUDY_DIRECTORYan Bi, MD,PhD
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed