Clinical trial NCT05416970: The Influence of SARS-CoV-2 Lifestyle Changes on Non-alcoholic Fatty Liver Disease Evolution
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: SARS-CoV-2
non-alcoholic fatty liver disease
Bioelectrical impedance analysis
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of body free fat mass
timeFrame: from January 2018 to January 2022
measure: Changes of body fat mass
timeFrame: from January 2018 to January 2022
measure: Changes of body cell mass
timeFrame: from January 2018 to January 2022
measure: Changes of body Skeletal-Muscle-Mass
timeFrame: from January 2018 to January 2022
measure: Changes of body SMM-Index
timeFrame: from January 2018 to January 2022
measure: Statistically significant worsening of waist/hip ratio
timeFrame: from January 2018 to January 2022
measure: Statistically significant worsening of fasting plasma glucose
timeFrame: from January 2018 to January 2022
measure: Statistically significant worsening of blood pressure
timeFrame: from January 2018 to January 2022
measure: Statistically significant worsening high density lipoprotein
timeFrame: from January 2018 to January 2022
measure: Statistically significant worsening triglycerides
timeFrame: from January 2018 to January 2022
Secondary outcomes:
measure: rate of hepatocellular carcinoma occurrence
timeFrame: from January 2018 to January 2022
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Alessandro Federico, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
citation: Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.
citation: Associazione Italiana per lo Studio del Fegato (AISF), Societa Italiana di Diabetologia (SID) and Societa Italiana dell'Obesita (SIO); Members of the guidelines panel; Coordinator; AISF Members; SID Members; SIO Members; Metodologists. Non-alcoholic fatty liver disease in adults 2021: A clinical practice guideline of the Italian Association for the Study of the Liver (AISF), the Italian Society of Diabetology (SID) and the Italian Society of Obesity (SIO). Nutr Metab Cardiovasc Dis. 2022 Jan;32(1):1-16. doi: 10.1016/j.numecd.2021.04.028. Epub 2021 Dec 16.