Metabolic Associated Fatty Liver DiseaseNCT04761900
MAFLD-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes
An observational study of Metabolic Associated Fatty Liver Disease, run by Ningbo No. 1 Hospital.
Trial summary
Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease
- What is being tested?
- the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases
- How many people
- 3,372 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2020
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Chinese adults who took annual health check-ups were enrolled in this study during 2012.
Who may be able to join
- diagnosed ad fatty liver by ultrasound
Who cannot join
- Missing data on Ultrasound, blood glucose, BMI and metabolic status.
About this study
Official title: Metabolic Associated Fatty Liver Disease-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes in Real World
Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver diseases. It affects nearly 25% of the global population. Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries. It may provide a better understanding of MAFLD, and optimize strategies for prevention of extrahepatic complications in clinical practice.
- Conditions
- Metabolic Associated Fatty Liver Disease
- Being tested
- the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseasesDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| participants were followed for the incidence of T2DM in a cohort study | performed a cohort analysis for T2DM. For incident T2DM cases, calculate the follow-up time from the date of enrollment into our study to the date of T2DM diagnosis. Receives: Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases | |
| participants were followed for the incidence of hypertension in a cohort study | performed a cohort analysis for hypertension. For incident hypertension cases, calculate the follow-up time from the date of enrollment into our study to the date of hypertension diagnosis. Receives: Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases | |
| participants were followed for the incidence of carotid atherosclerotic plaque in a cohort study | performed a cohort analysis for carotid atherosclerotic plaque. For incident carotid atherosclerotic plaque cases, calculate the follow-up time from the date of enrollment into our study to the date of carotid atherosclerotic plaque diagnosis. Receives: Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of T2DM, hypertension, and carotid atherosclerotic plaque.
We performed the cohort analysis for the outcome of T2DM. T2DM was defined as the presence of any of the following conditions based on the American Diabetes Association criteria: FPG ≥126 mg/dL, HbA1c ≥6.5%; or self-reported clinician-diagnosed T2DM.
Measured: 7 years in a cohort study
Secondary outcomes (2)
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of hypertension
We performed the cohort analysis for the outcome of hypertension. Hypertension was defined as the presence of any of the following conditions based on Revised Chinese Guidelines for Prevention and Treatment of Hypertension in 2018: a clinic systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg without the use of anti-hypertensive medications, or self-reported clinician-diagnosed hypertension.
Measured: 7 years in a cohort study
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of carotid atherosclerotic plaque.
We performed the cohort analysis for the outcome of carotid atherosclerotic plaque.
Carotid atherosclerotic plaque was assessed by recording ultrasonographic images of the right carotid artery according to Mannheim Intima-Media Thickness Consensus.
Measured: 7 years in a cohort study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated 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
- 3,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengfu Xu, Dr, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761900
- Sponsor's protocol ID
- MAFLDS-1.0
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Associated Fatty Liver Disease-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes in Real World
- ClinicalTrials.gov ID
- NCT04761900
- Acronym / sponsor ID
- MAFLDS-1.0
- Conditions
- Metabolic Associated Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,372 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Feb 2021 (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.
Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver diseases. It affects nearly 25% of the global population. Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries. It may provide a better understanding of MAFLD, and optimize strategies for prevention of extrahepatic complications in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| participants were followed for the incidence of T2DM in a cohort study | – | Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseasesperformed a cohort analysis for T2DM. For incident T2DM cases, calculate the follow-up time from the date of enrollment into our study to the date of T2DM diagnosis. |
| participants were followed for the incidence of hypertension in a cohort study | – | Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseasesperformed a cohort analysis for hypertension. For incident hypertension cases, calculate the follow-up time from the date of enrollment into our study to the date of hypertension diagnosis. |
| participants were followed for the incidence of carotid atherosclerotic plaque in a cohort study | – | Diagnostic Test: the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseasesperformed a cohort analysis for carotid atherosclerotic plaque. For incident carotid atherosclerotic plaque cases, calculate the follow-up time from the date of enrollment into our study to the date of carotid atherosclerotic plaque diagnosis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese adults who took annual health check-ups were enrolled in this study during 2012.
Key inclusion criteria (1 listed)
- diagnosed ad fatty liver by ultrasound
Key exclusion criteria (1 listed)
- Missing data on Ultrasound, blood glucose, BMI and metabolic status.
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 |
|---|---|---|
| the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases | Diagnostic test | participants were followed for the incidence of T2DM in a cohort study, participants were followed for the incidence of carotid atherosclerotic plaque in a cohort study, participants were followed for the incidence of hypertension in a cohort study |
Primary outcome
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of T2DM, hypertension, and carotid atherosclerotic plaque.
Time frame: 7 years in a cohort study
We performed the cohort analysis for the outcome of T2DM. T2DM was defined as the presence of any of the following conditions based on the American Diabetes Association criteria: FPG ≥126 mg/dL, HbA1c ≥6.5%; or self-reported clinician-diagnosed T2DM.
2 secondary outcomes
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of hypertension
Time frame: 7 years in a cohort study
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of carotid atherosclerotic plaque.
Time frame: 7 years in a cohort study
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 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Chengfu Xu, Dr principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Associated Fatty Liver Disease, run by Ningbo No. 1 Hospital.
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 1 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of T2DM, hypertension, and carotid atherosclerotic plaque. (time frame: 7 years in a cohort study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.