Non-Alcoholic Fatty Liver DiseaseNCT05416970
The Influence of SARS-CoV-2 Lifestyle Changes on Non-alcoholic Fatty Liver Disease Evolution
An observational study of Non-Alcoholic Fatty Liver Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGES
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 122 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- NAFLD diagnosis based on clinical, biochemical, imaging and/or histology
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGES
- Keywords
- SARS-CoV-2, non-alcoholic fatty liver disease, Bioelectrical impedance analysis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| non-alcoholic fatty liver disease affected patients | 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. Receives: Behavioral: SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from January 2018 to January 2022
Secondary outcomes (1)
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
Measured: from January 2018 to January 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jan 2018
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Federico, University of Campania Luigi Vanvitelli
- Investigators
- Alessandro Federico, Professor, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416970
- Sponsor's protocol ID
- 15.04-20220010000
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data that underlie results in a publication are available for the IPD sharing process upon reasonable request to the principal investigator. The access to the data will be granted to Researchers who provide a methodologically sound proposal. Proposals should be directed to alessandro.federico@unicampania.it or marcello.dallio@unicampania.it. To gain access, data requestors will need to sign a data access agreement. Data are available starting 6 months after publication for 10 years.
Publications
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.
PubMed 27062661Chalasani 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.
PubMed 28714183Associazione 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.
PubMed 34924246
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05416970
- Acronym / sponsor ID
- 15.04-20220010000
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- SARS-CoV-2, non-alcoholic fatty liver disease, Bioelectrical impedance analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-alcoholic fatty liver disease affected patients | – | Behavioral: SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGESPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- NAFLD diagnosis based on clinical, biochemical, imaging and/or histology
Key exclusion criteria (13 listed)
- diagnosis of inflammatory bowel disease,
- diagnosis of acute kidney disease
- diagnosis of chronic kidney disease
- diagnosis of rheumatoid arthritis
- diagnosis of systemic lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPERIMPOSED SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-CoV-2) LIFESTYLE CHANGESTo 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. | Behavioural | non-alcoholic fatty liver disease affected patients |
Primary outcome
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).
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).
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).
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).
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).
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
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
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
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
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
1 secondary outcome
rate of hepatocellular carcinoma occurrence
Time frame: from January 2018 to January 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Background: PubMed 27062661European 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.
- Background: PubMed 28714183Chalasani 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.
- Background: PubMed 34924246Associazione 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.
- Individual participant dataSharing planned: Yes. All the data that underlie results in a publication are available for the IPD sharing process upon reasonable request to the principal investigator. The access to the data will be granted to Researchers who provide a methodologically sound proposal. Proposals should be directed to alessandro.federico@unicampania.it or marcello.dallio@unicampania.it. To gain access, data requestors will need to sign a data access agreement. Data are available starting 6 months after publication for 10 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Federico, Professor principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of body free fat mass (time frame: from January 2018 to January 2022). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416970, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.