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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGES

Study type: Observational

Funder types: Other

Identifiers

NCT05416970

15.04-20220010000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

122 participants in 1 patient group

non-alcoholic fatty liver disease affected patients

Description:

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.

Treatment:

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