背景:非酒精性脂肪性肝病(NAFLD)是一种全球性的健康流行病。生活方式干预被推荐为NAFLD的主要治疗方法。然而,最优方法尚不清楚。这项研究旨在评估强化生活方式干预(ILI)的综合方法的效果,以加强对热量限制饮食(CRD)的控制。锻炼,和个性化营养咨询对中国超重和肥胖NAFLD患者肝脏脂肪变性和肝外代谢状态的影响。
方法:本研究是一项多中心随机对照试验(RCT),在中国7家医院进行。它涉及226名体重指数(BMI)高于25的参与者。这些参与者被随机分为两组:ILI组,接着是低碳水化合物,高蛋白CRD结合运动和营养师的强化咨询,和一个对照组,坚持平衡的CRD以及锻炼和标准咨询。研究的主要测量是从研究开始到第12周的脂肪衰减参数(FAP)的变化,在每个协议集内进行分析。次要指标包括BMI的变化,肝脏硬度测量(LSM),和各种代谢指标的改善。此外,FAP的预定亚组分析是根据性别等变量进行的,年龄,BMI,种族,高脂血症,和高血压。
结果:共有167名参与者完成了整个研究。与对照组相比,ILI参与者实现了FAP的显著降低(LS均值差异,16.07[95%CI:8.90-23.25]dB/m)和BMI(LS均值差,1.46[95%CI:1.09-1.82]kg/m2),但不在LSM改善中(LS平均差,0.20[95%CI:-0.19-0.59]kPa)。ILI还显著改善了其他次要结局(包括ALT,AST,GGT,身体脂肪量,肌肉质量和骨骼肌质量,甘油三酯,空腹血糖,空腹胰岛素,HbA1c,HOMA-IR,HOMA-β,血压,和高半胱氨酸)。进一步的亚组分析表明,ILI,而不是控制干预,导致更显著的FAP降低,尤其是并发高血压患者(p<0.001)。
结论:在此RCT中,一项为期12周的强化生活方式干预计划可显著改善超重和肥胖的中国非酒精性脂肪肝患者的肝脏脂肪变性和其他代谢指标.需要进一步的研究来确认这种方法的长期优势和实用性。
背景:该临床试验于2019年6月在ClinicalTrials.gov(注册号:NCT03972631)上注册。
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a globally increasing health epidemic. Lifestyle intervention is recommended as the main therapy for NAFLD. However, the optimal approach is still unclear. This study aimed to evaluate the effects of a comprehensive approach of intensive lifestyle intervention (ILI) concerning enhanced control of calorie-restricted diet (CRD), exercise, and personalized nutrition counseling on liver steatosis and extrahepatic metabolic status in Chinese overweight and
obese patients with NAFLD.
METHODS: This study was a multicenter randomized controlled trial (RCT) conducted across seven hospitals in
China. It involved 226 participants with a body mass index (BMI) above 25. These participants were randomly assigned to two groups: the ILI group, which followed a low carbohydrate, high protein CRD combined with exercise and intensive counseling from a dietitian, and a control group, which adhered to a balanced CRD along with exercise and standard counseling. The main measure of the study was the change in the fat attenuation parameter (FAP) from the start of the study to week 12, analyzed within the per-protocol set. Secondary measures included changes in BMI, liver stiffness measurement (LSM), and the improvement of various metabolic indexes. Additionally, predetermined subgroup analyses of the FAP were conducted based on variables like gender, age, BMI, ethnicity, hyperlipidemia, and hypertension.
RESULTS: A total of 167 participants completed the whole study. Compared to the control group, ILI participants achieved a significant reduction in FAP (LS mean difference, 16.07 [95% CI: 8.90-23.25] dB/m) and BMI (LS mean difference, 1.46 [95% CI: 1.09-1.82] kg/m2) but not in LSM improvement (LS mean difference, 0.20 [95% CI: -0.19-0.59] kPa). The ILI also substantially improved other secondary outcomes (including ALT, AST, GGT, body fat mass, muscle mass and skeletal muscle mass, triglyceride, fasting blood glucose, fasting insulin, HbA1c, HOMA-IR, HOMA-β, blood pressure, and homocysteine). Further subgroup analyses showed that ILI, rather than control intervention, led to more significant FAP reduction, especially in patients with concurrent hypertension (p < 0.001).
CONCLUSIONS: In this RCT, a 12-week intensive lifestyle intervention program led to significant improvements in liver steatosis and other metabolic indicators in overweight and
obese Chinese patients suffering from nonalcoholic fatty liver disease. Further research is required to confirm the long-term advantages and practicality of this approach.
BACKGROUND: This clinical trial was registered on ClinicalTrials.gov (registration number: NCT03972631) in June 2019.