Skip to content

Clinical Characteristics of Metabolic Associated Fatty Liver Disease

A Multicenter, Retrospective Clinical Study on the Clinical Characteristics of Metabolic Associated Fatty Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06325254
Enrollment
3000
Registered
2024-03-22
Start date
2010-01-01
Completion date
2024-08-31
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Features, Metabolic Associated Fatty Liver Disease

Keywords

Metabolic associated fatty liver disease, Clinical features

Brief summary

Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.

Detailed description

Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.

Interventions

None listed

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 18 years or older; 2. MAFLD patients

Exclusion criteria

1. malignant tumors; 2. mental illness, severe impairment of cardiopulmonary function, severe renal insufficiency, severe infections, and cerebrovascular accidents; 3. received liver or other organ transplants.

Design outcomes

Primary

MeasureTime frameDescription
Clinical characteristics and follow-up outcomes of MAFLD patients480 weeks1. Clinical characteristic related indicators: height (m), weight (kg), waist circumference (cm), previous history (T2DM, HT, dyslipidemia), SBP (mmHg), DBP (mmHg), alcohol intake (g/week), smoking, blood routine \[WBC (109/L), Hb (g/L), PLT (109/L)\], CRP (mg/L), biochemical indicators \[TB (umol/L), ALB (g/L), ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L), TC (mmol/L), TG (mmol/L), HDL (mmol/L), LDL (mmol/L)\], blood glucose indicators \[FBG (mmol/L), PBG (mmol/L), HA1c (%)\], coagulation \[PT (s), INR\], AFP (ng/ml), transient elastography \[LSM (Kpa), ACP (dB/m)\], liver CT/MRI/B type ultrasound. 2. Follow up outcome data: mortality and causes of death, incidence of complications (ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, intrahepatic and extrahepatic malignancies, infection, cardiovascular and cerebrovascular diseases, or all-cause mortality).

Secondary

MeasureTime frameDescription
Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups480 weeks1. Subgroups: Age (\<40 years and ≥40 years), gender (male and female), steatosis stage according to CT/MRI/B type ultrasound (Mild, moderate, and severe), and MASH status (non-MASH and MASH) 2. Clinical characteristic related indicators: height (m), weight (kg), waist circumference (cm), previous history (T2DM, HT, dyslipidemia), SBP (mmHg), DBP (mmHg), alcohol intake (g/week), smoking, WBC (109/L), Hb (g/L), PLT (109/L), TB (umol/L), ALB (g/L), ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L), TC (mmol/L), TG (mmol/L), HDL (mmol/L), LDL (mmol/L), FBG (mmol/L), PBG (mmol/L), HA1c (%), PT (s), INR, AFP (ng/ml), transient elastography \[LSM (Kpa), ACP (dB/m)\], liver CT/MRI/B type ultrasound, liver histology. 3. Follow up outcome data: mortality and causes of death, incidence of complications.
Baseline clinical characteristics MAFLD patients0 weeksClinical characteristic related indicators: height (m), weight (kg), waist circumference (cm), previous history (T2DM, HT, dyslipidemia), SBP (mmHg), DBP (mmHg), alcohol intake (g/week), smoking, blood routine \[WBC (109/L), Hb (g/L), PLT (109/L)\], CRP (mg/L), biochemical indicators \[TB (umol/L), ALB (g/L), ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L), TC (mmol/L), TG (mmol/L), HDL (mmol/L), LDL (mmol/L)\], blood glucose indicators \[FBG (mmol/L), PBG (mmol/L), HA1c (%)\], coagulation \[PT (s), INR\], AFP (ng/ml), transient elastography \[LSM (Kpa), ACP (dB/m)\], liver CT/MRI/B type ultrasound.
Risk factors for progression to cirrhosis and hepatocellular carcinoma480 weeksRisk factors for progression to cirrhosis and hepatocellular carcinoma in MAFLD patients

Countries

China

Contacts

Primary ContactJie Li, M.D.,Ph.D
lijier@nju.edu.cn15863787910
Backup ContactQianqian Chen
qian_1395692197@126.com18360722012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026