Effect of High Intensity Exercise Rehabilitation on Hepatic Fatty Acids (Liver Function), Insulin Sensitivity and Cardiovascular Risk in Patients With MASLD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Liver steatosis by CAP
研究概览
简要总结
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.
In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent.
详细描述
Physical activity and lifestyle interventions, including exercise, are recommended for individuals with metabolic dysfunction-associated steatotic liver disease (MASLD). Weight loss has been found to improve MASLD histologically, but exercise alone can also reduce liver fat accumulation, even without significant weight loss. Exercise has positive effects on chronic inflammation, type 2 diabetes mellitus (T2DM), and mitochondrial function in MASLD patients. Studies suggest that both aerobic and resistance exercise are effective in reducing fat content and liver enzyme levels in MASLD, and thereby generate positive effects on insulin sensitivity and cardiovascular risk. The potential of high-intensity interval training (HIIT) is large in various settings, but was never explored in this population. Moreover, the combination with strength training can have additional health effects which remain to be explored.
All subjects are recruited in the liver steatosis outpatient clinic of the university hospital in Ghent by the physicians and researchers of this study. After patient selection and obtaining informed consent, they will be screened in the rehabilitation center for cardiorespiratory fitness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The training will be given by the care provider, but in exercise therapy it is not possible to mask. The assessor will assess the patients without knowing in which group they will be randomized. Randomization will be done by an external person who is only involved for randomization. The investigator, who will be analysing data afterwords, will only see 1 or 2 as group number, but will not know which number is corresponding to which group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MASLD by ultrasound, CAP and/or biopsy
- •Age between 18 and 75 years old
- •No significant liver fibrosis (Fibroscan < 7.5 kPa; if it is between >7.5 and <10, there must be absence of liver fibrosis in the biopsy)
排除标准
- •Presence of other liver diseases that may contribute to the clinical presentation in the patient
- •Severe cardiovascular, orthopedic, physical or other illnesses that make it impossible to participate in the study's exercise rehabilitation program or where safety cannot be guaranteed
- •Pregnancy
- •Pharmacological treatment that directly affects MASLD (e.g. GLP-1 analogues)
- •A change in medication in the last three months before the study that affects metabolic disease stability
结局指标
主要结局
Liver steatosis by CAP
时间窗: before training and after training (14 weeks)
Liver stiffness measurement will be performed using vibration-controlled transient elastography, more specifically the Fibroscan. This method measures the fat accumulation in the liver (dB/m) and the level of scar tissue (kPa), represented as the CAP or steatosis score and the fibrosis score respectively.
Liver steatosis on ultrasound
时间窗: before training and after training (14 weeks)
Ultrasound can demonstrate hepatic fatty tissue, estimating severity based on liver-kidney contrast, resolution loss thv the intrahepatic blood vessels, and visibility of the diaphragm. On this basis, a score 0-3 can be assigned.
次要结局
- Strength(before training and after training (14 weeks))
- Cardiovascular function(before training and after training (14 weeks))
- waist(before training and after training (14 weeks))
- TNF-alfa(before training and after training (14 weeks))
- Hepatokines(before training and after training (14 weeks))
- Maximal exercise test(before training and after training (14 weeks))
- Interleukine(before training and after training (14 weeks))
- Adipokines(before training and after training (14 weeks))
- BMI(before training and after training (14 weeks))
- BIA(before training and after training (14 weeks))
- SF-36(before training and after training (14 weeks))
- Insulin sensitivity(before training and after training (14 weeks))
- Myokines(before training and after training (14 weeks))
- Liver transaminases(before training and after training (14 weeks))
- Weight(before training and after training (14 weeks))
- Heigth(before training and after training (14 weeks))