Effect of Intermittent Calorie Restriction on Metabolic Dysfunction-Associated Steatotic Liver Disease Patients With Abnormal Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Liver Fat Content in %
研究概览
简要总结
This study is designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in MASLD patients with abnormal blood glucose.
详细描述
Intermittent caloric restriction (ICR) can effectively reduce weight and facilitate blood glucose control, but whether it can be applied for clinical treatment to metabolic dysfunction-associated steatotic liver disease (MASLD) patients remains unclear. We intend to carry out this study in MASLD patients with abnormal glucose metabolism. It is an open-labeled randomized trial designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in MASLD patients with abnormal blood glucose. 60 patients will be randomly divided into ICR group and control group for 12 weeks of intervention. ICR group: during the 2-day fasting-mimicking period each week, the food based on plant ingredients will be served (4 pieces of nutrition bars / day, 1:2:1 for breakfast, lunch and dinner, 124.4kcal / piece, 497.2kcal / day in total). In the rest 5 days each week, subjects are allowed ad libitum to their usual food. Control group (continuous calorie restriction, CCR): under the guidance of nutritionist, subjects have to learn the method of food calories calculation. The daily calories intake for control group should be: 25 kcal / kg × [height (cm) - 100] kg. Daily food diary is required in both groups. During the experiment, all subjects should maintain their exercise routine. The use of drugs affecting blood glucose and fatty liver should be avoided. After 12 weeks of intervention, the changes of liver fat content were evaluated by magnetic resonance spectroscopy (MRS) and Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF). The effects of ICR on body weight, blood glucose and body fat will also be evaluated. Both groups will be followed up on their changes of weight 4 weeks after intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70
- •Diagnosed as fatty liver by ultrasound or magnetic resonance imaging
- •BMI ≥ 24 kg/m2
- •abnormal glucose metabolism: (meeting at least one):
- •Impaired glucose regulation: fasting blood glucose ≥ 100 mg/dL, postprandial blood glucose ≥ 140 mg/dL or HbA1c ≥ 5.7%
- •Diabetes mellitus: diabetic symptoms + plasma glucose concentration ≥ 200 mg/dL at any time or fasting plasma glucose concentration ≥ 100 mg/dL or OGTT 2 h plasma glucose concentration ≥ 200 mg/dL
排除标准
- •Type 1 diabetes, gestational diabetes and other special types of diabetes
- •Poor blood glucose control, HbA1c > 8.5% within 3 months
- •Taking antidiabetic drugs in the past month
- •Serum ALT > 6 times of normal upper limit
- •Excessive alcohol consumption (alcohol intake: men > 140 g, women > 70 g in the past 6 months)
- •Other liver diseases: such as acute and chronic viral hepatitis, drug-induced hepatitis, immune hepatitis, liver cirrhosis, liver cancer, etc
- •Taking drugs that may affect MASLD in the past three months, such as vitamin E
- •Biliary obstructive diseases
- •Other diseases affecting glucose and lipid metabolism: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc
- •Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)
- •Life expectancy of no more than 5 years
- •Already pregnant or plan to be pregnant in the near future
- •Mental illness
- •Other conditions affecting follow-up
- •Have participated in other clinical trials in the past 4 weeks
- •Absent of informed consent
结局指标
主要结局
Change of Liver Fat Content in %
时间窗: From baseline to week 12
Change of liver fat content in %.
次要结局
- Change of Weight(From baseline to week 12)
- Change of Blood Glucose: Fasting Blood Glucose(From baseline to week 12)
- Change of Blood Glucose: 2h Postload Blood Glucose(From baseline to week 12)
- Change of HbA1c(From baseline to week 12)
- Change of Liver Enzymes: Alanine Aminotransferase(From baseline to week 12)
- Change of Liver Enzymes: Aspartate Aminotransferase(From baseline to week 12)
- Change of Liver Enzymes: γ-glutamyl Transpeptidase(From baseline to week 12)
- Change of Lipid Profile: Total Cholesterol(From baseline to week 12)
- Change of Lipid Profile: Triglyceride(From baseline to week 12)
- Change of Lipid Profile: High-density Lipoprotein-cholesterol(From baseline to week 12)
- Change of Lipid Profile: Low-density Lipoprotein-cholesterol(From baseline to week 12)
- Change of Lipid Profile: Free Fatty Acid(From baseline to week 12)
研究者
Hua Bian
Director
Shanghai Zhongshan Hospital