NCT04573283

Brief Summary

Metabolic dysfunction-associated fatty liver disease (MAFLD) is a new concept proposed in 2020. Unlike non-alcoholic fatter liver disease (NAFLD), the diagnosis of MAFLD requires the presence any of the following 3 metabolic risks, including overweight/obesity, presence of diabetes mellitus, and evidence of metabolic dysregulation. However, there are patients that have hepatic steatosis but no metabolic risk, who thus do not meet the diagnostic criteria of MAFLD. Besides, there are patients with both MAFLD and other liver diseases. The clinical features and the management of these patients remain unclear. Thus, further histopathological and clinical study is required to elucidate and compare the characteristics of MAFLD and NAFLD. Here, in this single-center, prospective clinical study, investigators are planning to establish a long-term follow-up cohort of patients with either MAFLD or NAFLD. In order to understand the risk of developing liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease), and also to better elucidate the risk of disease progression in "lean" NAFLD individuals without any metabolic dysregulation and MAFLD individuals with dual or multiple causes. Ultimately, investigators aim to improve the diagnosis of MAFLD and improve patients' outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2020Aug 2030

Study Start

First participant enrolled

August 17, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2030

Last Updated

February 9, 2021

Status Verified

September 1, 2020

Enrollment Period

10 years

First QC Date

September 27, 2020

Last Update Submit

February 4, 2021

Conditions

Metabolic Associated Fatty Liver Disease

Keywords

metabolic associated fatty liver diseasemetabolicnonalcoholic fatty liver disease (NAFLD)non-MR-NAFLD

Outcome Measures

Primary Outcomes (1)

  • All cause death

    Noticed death of patient at follow-up visit

    10 years

Secondary Outcomes (2)

  • Liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease)

    10 years

  • The correlation between different metabolic components and the clinical manifestations and disease progression

    10 years

Other Outcomes (1)

  • The clinical manifestations and differences of metabolic-related fatty liver disease combine with different liver diseases

    10 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study include 3000 patients diagnosed as hepatic steatosis (both inpatients and outpatients of Nanfang hospital). We exclude the patients with history of liver transplantation, history of hepatocellular carcinoma (HCC) or other active malignancy, congestive heart failure and serious cerebrovascular disease, and pregnancy.

You may qualify if:

  • Diagnosed as hepatic steatosis in adults (fulfill at least one of the followings):
  • Liver ultrasound shows liver parenchymal hyperechoic or "bright liver"
  • Controlled attenuation-parameter (CAP) ≥248dB/m
  • Hepatic steatosis diagnosed by CT/MRI/MRS
  • MRI-based proton-density fat fraction (MRI-PDFF) shows liver fat content\>8%
  • Fatty liver confirmed by liver histology.

You may not qualify if:

  • Diagnosed with hepatocellular carcinoma or other malignancy (in accordance with the appropriate diagnostic criteria);
  • During pregnancy;
  • Patients with history of liver transplantation;
  • Patients with serious cardiovascular and cerebrovascular events (such as acute myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5mL peripheral blood placed in sodium citrate vacuum tube, 5mL peripheral blood serum, 10mL random urine and 25g stool are collected at the baseline information and specimen collection. All these samples are used for screening potential indicators to evaluate prognosis.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Jinjun Chen

CONTACT

8618588531001chjj@smu.edu.cn

Ling Zhou

CONTACT

8613631383539vzhouling3168@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 5, 2020

Study Start

August 17, 2020

Primary Completion (Estimated)

August 17, 2030

Study Completion (Estimated)

August 17, 2030

Last Updated

February 9, 2021

Record last verified: 2020-09

Locations

CN(1)