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NCT Number: NCT05416970

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Campania "Luigi Vanvitelli"

Naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Changes of body free fat mass

    Time frame: from January 2018 to January 2022

    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).

  2. Changes of body fat mass

    Time frame: from January 2018 to January 2022

    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).

  3. Changes of body cell mass

    Time frame: from January 2018 to January 2022

    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).

  4. Changes of body Skeletal-Muscle-Mass

    Time frame: from January 2018 to January 2022

    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).

  5. Changes of body SMM-Index

    Time frame: from January 2018 to January 2022

    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).

  6. Statistically significant worsening of waist/hip ratio

    Time frame: from January 2018 to January 2022

    For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one

  7. Statistically significant worsening of fasting plasma glucose

    Time frame: from January 2018 to January 2022

    For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one

  8. Statistically significant worsening of blood pressure

    Time frame: from January 2018 to January 2022

    For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one

  9. Statistically significant worsening high density lipoprotein

    Time frame: from January 2018 to January 2022

    For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one

  10. Statistically significant worsening triglycerides

    Time frame: from January 2018 to January 2022

    For the entire length of the study biochemical and clinical parameters were collected comparing the values of pre pandemic period to the pandemic one

Secondary outcomes

  1. rate of hepatocellular carcinoma occurrence

    Time frame: from January 2018 to January 2022

    For the entire length of the study the new onset of HCC were recorded comparing the pre pandemic period to the pandemic one

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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