Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in c-reactive protein (CRP)
研究概览
简要总结
The purpose of this research study is to find out about the usefulness of mindfulness for weight loss and improvement of physical and mental health in people who have non-alcoholic fatty liver disease (NAFLD).
详细描述
Adding mindfulness to lifestyle changes for weight loss may improve fatty liver disease in particular and overall health and well-being in general by helping sustain weight loss and maintain a healthy lifestyle. This study will allow researchers to learn more about it.
Non-alcoholic fatty liver disease is a condition where there is accumulation of excess fat in the liver of people who drink little or no alcohol. It is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids, as well as high blood pressure, all are risk factors for the disease.
In this study, participants will receive usual care, and in addition, they may be asked to participate in a mindfulness-based stress reduction program for 8 weeks. Usual care involves the routine clinic follow up visits and routine lab tests and imaging studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of NAFLD and ALT >35 U/dl.
- •At least 2 features of Metabolic syndrome (defined by Adult Treatment Panel III (2005 revision)).
- •Age 18-80 years.
- •BMI ≥25 Kg/m
- •Capable of providing written or signed informed consent.
排除标准
- •Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings.
- •Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy).
- •Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months.
- •Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment.
- •Unstable metabolic syndrome and other serious chronic medical conditions.
- •Unstable type 2 diabetes (any of the following):
- •Requiring medication adjustment within the last 3 months.
- •Patients requiring GLP-1 agonists treatment.
- •No more than 10% modification in insulin dose if on insulin.
- •If on SGLT-2 inhibitors, need to be on stable dose with more than 5% weight loss in the last 3 months.
- •Unable to adhere to out-patient clinic management program.
- •Do not speak English on a daily-user level.
- •Pregnant or planning to become pregnant within the following 6 months.
- •Active substance use disorder.
- •Does not accept follow-ups over 1 year from time of inclusion (T0).
结局指标
主要结局
Change in c-reactive protein (CRP)
时间窗: Baseline to 6 months
Relative change (%) in CRP at 6 months (T1) from baseline (T0).
Change in bilirubin
时间窗: Baseline to 6 months
Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
时间窗: Baseline to 6 months
Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).
Change in hepatic fat deposition
时间窗: Baseline to 6 months
Relative change (%) in hepatic fat deposition as measured by magnetic resonance imaging (MRI) with proton density fat fraction (PDFF) at 6 months (T1) from baseline (T0).
Change in total body weight
时间窗: Baseline to 6 months
Relative change (%) in total body weight at 6 months (T1) from baseline (T0).
Change in alanine transaminase (ALT)
时间窗: Baseline to 6 months
Relative change (%) in ALT at 6 months (T1) from baseline (T0).
Change in aspartate transaminase (AST)
时间窗: Baseline to 6 months
Relative change (%) in AST at 6 months (T1) from baseline (T0).
Change in alkaline phosphatase (ALP)
时间窗: Baseline to 6 months
Relative change (%) in ALP at 6 months (T1) from baseline (T0).
Change in Fibrosis-4 Index (FIB-4)
时间窗: Baseline to 6 months
Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).
Change in Enhanced Liver Fibrosis test (ELF)
时间窗: Baseline to 6 months
Relative change (%) in ELF at 6 months (T1) from baseline (T0).
Change in liver stiffness
时间窗: Baseline to 6 months
Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0).
次要结局
- Change in bilirubin(Baseline to 12 months)
- Change in aspartate transaminase (AST)(Baseline to 12 months)
- Change in Enhanced Liver Fibrosis test (ELF)(Baseline to 12 months)
- Change in alanine transaminase (ALT)(Baseline to 12 months)
- Change in alkaline phosphatase (ALP)(Baseline to 12 months)
- Change in total body weight(Baseline to 12 months)
- Change in Fibrosis-4 Index (FIB-4)(Baseline to 12 months)
- Change in c-reactive protein (CRP)(Baseline to 12 months)
- Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)(Baseline to 12 months)
- Change in hepatic fat deposition(Baseline to 12 months)