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

Официальное название

Effects of Aerobic or Resistance Exercise, or Both on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Changes of intrahepatic triglyceride contents [Срок оценки: Baseline, 12 weeks]

Вторичные конечные точки (12)

• Changes of liver transaminase [Срок оценки: Baseline, 12 weeks]
• Changes of liver fibrosis [Срок оценки: Baseline, 12 weeks]
• Changes of liver fibrosis degree [Срок оценки: Baseline, 12 weeks]
• Changes of FIB-4 index [Срок оценки: Baseline, 12 weeks]
• Changes of body weight [Срок оценки: Baseline, 12 weeks]
• Changes of body fat [Срок оценки: Baseline, 12 weeks]
• Changes of muscle mass [Срок оценки: Baseline, 12 weeks]
• Changes of muscle function [Срок оценки: Baseline, 12 weeks]
• Changes of HbA1c. [Срок оценки: Baseline, 12 weeks]
• Changes of blood glucose [Срок оценки: Baseline, 12 weeks]
• Changes of blood insulin [Срок оценки: Baseline, 12 weeks]
• Changes of lipid metabolism indexes [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

• 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%).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medi — Нанкин
• Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medi — Нанкин

Идентификаторы

NCT: NCT06994871 · 2024-880-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗