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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05130346
Other study ID # HM20023471
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2023
Est. completion date December 2023

Study information

Verified date February 2023
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness Based Stress Reduction (MBSR)
Participants will be asked to attend group meetings for mindfulness training. Each meeting will last approximately one hour and will take place online via Zoom. The meetings will occur on a weekly basis, over an 8-week period.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in total body weight Relative change (%) in total body weight at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in bilirubin Relative change (%) in bilirubin at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in alanine transaminase (ALT) Relative change (%) in ALT at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in aspartate transaminase (AST) Relative change (%) in AST at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in alkaline phosphatase (ALP) Relative change (%) in ALP at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in c-reactive protein (CRP) Relative change (%) in CRP at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in Fibrosis-4 Index (FIB-4) Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in Enhanced Liver Fibrosis test (ELF) Relative change (%) in ELF at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4) Relative change (%) in NIS4 at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in liver stiffness Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0). Baseline to 6 months
Primary Change in hepatic fat deposition 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). Baseline to 6 months
Secondary Change in total body weight Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in bilirubin Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in alanine transaminase (ALT) Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in aspartate transaminase (AST) Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in c-reactive protein (CRP) Relative change (%) in CRP at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in Fibrosis-4 Index (FIB-4) Relative change (%) in FIB-4 at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in Enhanced Liver Fibrosis test (ELF) Relative change (%) in ELF at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4) Relative change (%) in NIS4 at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in alkaline phosphatase (ALP) Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
Secondary Change in hepatic fat deposition Relative change (%) in hepatic fat deposition as measured by magnetic resonance imaging (MRI) with proton density fat fraction (PDFF) at 1 year (T2) from 6 months (T1) and baseline (T0). Baseline to 12 months
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