The Influence of SARS-CoV-2 Lifestyle Changes on Non-alcoholic Fatty Liver Disease Evolution

Study Overview
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Brief Summary
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Unhealthy lifestyle represents a key element fueling the non-alcoholic fatty liver disease (NAFLD) onset and worsening. The investigators aimed to evaluate the effects of confinement-related lifestyle changes experienced during the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic on NAFLD evolution. A retrospective cohort of NAFLD patients was followed two years before and two years during the pandemic. At three identified time points [baseline (January 2018: T0), intermediate (January 2020: T1), and end of study (January 2022: T2)], anthropometrical, biochemical, nutritional, bioelectrical impedance analysis (BIA) data and non-invasive tools measurements were collected.

Detailed Description
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The investigators performed a four years retrospective study on a NAFLD cohort from January 2018 to January 2022, dividing the study period in accordance to the beginning of the European SARS-CoV-2 spread in January 2020: two years before the pandemic followed by an equal period during the pandemic. The investigators routinely followed-up the enrolled patients with clinical, biochemical and imaging assessments in accordance with the current CPG and presented the data as mean values of the recordings occurred during the specific period of observation for insulin, fasting plasma glucose (FPG), the homeostatic model assessment for insulin resistance (HOMA-IR), aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelets count (PLT), plasma albumin. Baseline (T0), intermediate (at the end of the pre-pandemic period, January 2020: T1), and end of the study (January 2022 T2) weight, body mass index (BMI), liver stiffness measurement (LSM) and controlled attenuation parameter (CAP), NAFLD fibrosis score (NFS) and multicompartment bioimpedance body composition analysis were also performed. Moreover, a physical activity investigation in terms of hours per week of physical exercise and daily caloric intake were collected by administering a standardized questionnaire. The Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire was also recorded to assess alcohol consumption. For the entire length of the study, the investigators screened and eventually recorded hepatocellular carcinoma (HCC) occurrence by using ultrasonography assessments in accordance with CPG. The study primary endpoint was to assess the impact of the SARS-CoV-2 spread related lifestyle changes on body composition analysis and metabolic syndrome components worsening. Secondary endpoint was to assess the impact of the pandemic on HCC occurrence as well as shed light on the pandemic risk factors for HCC onset.

Official Title
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The Influence of Superimposed Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Lifestyle Changes on Non-alcoholic Fatty Liver Disease Evolution: a Matter of Body Composition

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - NAFLD diagnosis based on clinical, biochemical, imaging and/or histology Exclusion Criteria: diagnosis of inflammatory bowel disease, diagnosis of acute kidney disease diagnosis of chronic kidney disease diagnosis of rheumatoid arthritis diagnosis of systemic lupus erythematosus diagnosis of other major systemic autoimmune diseases diagnosis of tumors diagnosis of ongoing infections diagnosis of alcohol or drug abuse diagnosis of other etiologies of chronic liver damage diagnosis of previous HCC use of hepatoprotective drugs psychological/psychiatric problems that could have invalidate the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-alcoholic fatty liver disease affected patients<br>Patients affected by NAFLD based on clinical, biochemical, imaging and histology, in accordance to CPG diagnostic criteria, continuously followed by the Hepato-gastroenterology Division of the University of Campania Luigi Vanvitelli, between January 2018 and January 2022 were enrolled, after signing an informed consent, in the present study. | Behavioral: SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGES<br>* To assess the impact of the SARS-CoV-2 spread related lifestyle changes on body composition analysis and metabolic syndrome components worsening as well as hepatocellular carcinoma occurrence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of body free fat mass | A multifrequency bioelectrical impedance analysis (BIA) system (InBody, Seoul, Korea) was used to perform the body composition assessment. For the analysis, two electrodes on the right foot and hand were placed. Using the reactance (Xc), resistance (R) and phase angle [arctangent (Xc/R) × (180/π)] the BIA system, thanks to a series of machineries algorithms elaborated the total body water (TBW), the intracellular and extracellular body water (ICW/ECW), the FFM, the FM, body cell mass (BCM) expressed both in percentage and kilograms (Kg), Skeletal-Muscle-Mass (SMM) in Kg. SMM-Index (SMMI) was calculated by dividing the SMM by the square of the height (m2). | from January 2018 to January 2022 | 
| Changes of body fat mass | A multifrequency bioelectrical impedance analysis (BIA) system (InBody, Seoul, Korea) was used to perform the body composition assessment. For the analysis, two electrodes on the right foot and hand were placed. Using the reactance (Xc), resistance (R) and phase angle [arctangent (Xc/R) × (180/π)] the BIA system, thanks to a series of machineries algorithms elaborated the total body water (TBW), the intracellular and extracellular body water (ICW/ECW), the FFM, the FM, body cell mass (BCM) expressed both in percentage and kilograms (Kg), Skeletal-Muscle-Mass (SMM) in Kg. SMM-Index (SMMI) was calculated by dividing the SMM by the square of the height (m2). | from January 2018 to January 2022 | 
| Changes of body cell mass | A multifrequency bioelectrical impedance analysis (BIA) system (InBody, Seoul, Korea) was used to perform the body composition assessment. For the analysis, two electrodes on the right foot and hand were placed. Using the reactance (Xc), resistance (R) and phase angle [arctangent (Xc/R) × (180/π)] the BIA system, thanks to a series of machineries algorithms elaborated the total body water (TBW), the intracellular and extracellular body water (ICW/ECW), the FFM, the FM, body cell mass (BCM) expressed both in percentage and kilograms (Kg), Skeletal-Muscle-Mass (SMM) in Kg. SMM-Index (SMMI) was calculated by dividing the SMM by the square of the height (m2). | from January 2018 to January 2022 | 
| Changes of body Skeletal-Muscle-Mass | A multifrequency bioelectrical impedance analysis (BIA) system (InBody, Seoul, Korea) was used to perform the body composition assessment. For the analysis, two electrodes on the right foot and hand were placed. Using the reactance (Xc), resistance (R) and phase angle [arctangent (Xc/R) × (180/π)] the BIA system, thanks to a series of machineries algorithms elaborated the total body water (TBW), the intracellular and extracellular body water (ICW/ECW), the FFM, the FM, body cell mass (BCM) expressed both in percentage and kilograms (Kg), Skeletal-Muscle-Mass (SMM) in Kg. SMM-Index (SMMI) was calculated by dividing the SMM by the square of the height (m2). | from January 2018 to January 2022 | 
| Changes of body SMM-Index | A multifrequency bioelectrical impedance analysis (BIA) system (InBody, Seoul, Korea) was used to perform the body composition assessment. For the analysis, two electrodes on the right foot and hand were placed. Using the reactance (Xc), resistance (R) and phase angle [arctangent (Xc/R) × (180/π)] the BIA system, thanks to a series of machineries algorithms elaborated the total body water (TBW), the intracellular and extracellular body water (ICW/ECW), the FFM, the FM, body cell mass (BCM) expressed both in percentage and kilograms (Kg), Skeletal-Muscle-Mass (SMM) in Kg. SMM-Index (SMMI) was calculated by dividing the SMM by the square of the height (m2). | from January 2018 to January 2022 | 
| Statistically significant worsening of waist/hip ratio | For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one | from January 2018 to January 2022 | 
| Statistically significant worsening of fasting plasma glucose | For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one | from January 2018 to January 2022 | 
| Statistically significant worsening of blood pressure | For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one | from January 2018 to January 2022 | 
| Statistically significant worsening high density lipoprotein | For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one | from January 2018 to January 2022 | 
| Statistically significant worsening triglycerides | For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one | from January 2018 to January 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of hepatocellular carcinoma occurrence | For the entire length of the study the new onset of HCC were recorded comparing the pre pandemic period to the pandemic one | from January 2018 to January 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, non-alcoholic fatty liver disease, Bioelectrical impedance analysis