Clinical Characteristics of Metabolic Associated Fatty Liver Disease

Recruiting

• Conditions: Metabolic Associated Fatty Liver Disease; Clinical Features

• Registration Number: NCT06325254
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study Start: 2010-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical characteristics and follow-up outcomes of MAFLD patients	480 weeks	1. 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 Outcome Measures

Name	Time	Method
Risk factors for progression to cirrhosis and hepatocellular carcinoma	480 weeks	Risk factors for progression to cirrhosis and hepatocellular carcinoma in MAFLD patients
Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups	480 weeks	1. 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 patients	0 weeks	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.

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China