Non-Alcoholic Fatty Liver Disease Clinical Trial
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
Verified date | June 2022 |
Source | University of Campania "Luigi Vanvitelli" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Campania "Luigi Vanvitelli" | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Associazione Italiana per lo Studio del Fegato (AISF), Società Italiana di Diabetologia (SID) and Società Italiana dell'Obesità (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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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/p)] 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 | |
Primary | 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/p)] 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 | |
Primary | 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/p)] 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 | |
Primary | 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/p)] 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 | |
Primary | 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/p)] 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 |
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