Obesity Clinical Trial
Official title:
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
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Status | Withdrawn |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 |
Verified date | February 2023 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
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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