Clinical trial NCT05130346: Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease
Official title: Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Fatty Liver, Nonalcoholic
Obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of NAFLD and ALT \>35 U/dl.
2. At least 2 features of Metabolic syndrome (defined by Adult Treatment Panel III (2005 revision)).
3. Age 18-80 years.
4. BMI ≥25 Kg/m2.
5. Capable of providing written or signed informed consent.

Exclusion Criteria:

1. Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings.
2. Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy).
3. Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months.
4. Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment.
5. Unstable metabolic syndrome and other serious chronic medical conditions.
6. 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.
7. Unable to adhere to out-patient clinic management program.
8. Do not speak English on a daily-user level.
9. Pregnant or planning to become pregnant within the following 6 months.
10. Active substance use disorder.
11. Does not accept follow-ups over 1 year from time of inclusion (T0).
12. Inmates.

Primary outcomes:
measure: Change in total body weight
timeFrame: Baseline to 6 months
measure: Change in bilirubin
timeFrame: Baseline to 6 months
measure: Change in alanine transaminase (ALT)
timeFrame: Baseline to 6 months
measure: Change in aspartate transaminase (AST)
timeFrame: Baseline to 6 months
measure: Change in alkaline phosphatase (ALP)
timeFrame: Baseline to 6 months
measure: Change in c-reactive protein (CRP)
timeFrame: Baseline to 6 months
measure: Change in Fibrosis-4 Index (FIB-4)
timeFrame: Baseline to 6 months
measure: Change in Enhanced Liver Fibrosis test (ELF)
timeFrame: Baseline to 6 months
measure: Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
timeFrame: Baseline to 6 months
measure: Change in liver stiffness
timeFrame: Baseline to 6 months
measure: Change in hepatic fat deposition
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in total body weight
timeFrame: Baseline to 12 months
measure: Change in bilirubin
timeFrame: Baseline to 12 months
measure: Change in alanine transaminase (ALT)
timeFrame: Baseline to 12 months
measure: Change in aspartate transaminase (AST)
timeFrame: Baseline to 12 months
measure: Change in c-reactive protein (CRP)
timeFrame: Baseline to 12 months
measure: Change in Fibrosis-4 Index (FIB-4)
timeFrame: Baseline to 12 months
measure: Change in Enhanced Liver Fibrosis test (ELF)
timeFrame: Baseline to 12 months
measure: Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
timeFrame: Baseline to 12 months
measure: Change in alkaline phosphatase (ALP)
timeFrame: Baseline to 12 months
measure: Change in hepatic fat deposition
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Arun J Sanyal, MD
role: PRINCIPAL_INVESTIGATOR
References: