Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease
Reason given: The study is being withdrawn due to difficulties enrolling participants and the loss of the study coordinator
Key facts
- Where
- Richmond, United StatesSee the site
Where in United States
- Virginia Commonwealth UniversityRichmond, United StatesNo longer taking part
Trial details
- Who runs it
- Virginia Commonwealth University
- Trial code
- NCT05130346
- Record updated
- 8 February 2023
- Original description
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).Read full original descriptionShow less
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
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).
Inclusion: 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/m2; Capable of providing written or signed informed consent.
Exclusion: 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; Active substance use disorder; 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); 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; Does not accept follow-ups over 1 year from time of inclusion (T0); Inmates.