Clinical Characteristics of Metabolic Associated Fatty Liver Disease

Metabolic Associated Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325254
• Other study ID #: MAFLD
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Jie Li, M.D.,Ph.D
• Phone: 15863787910
• Email: lijier[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Features
• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical characteristics and follow-up outcomes of MAFLD patients	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.; 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).	480 weeks
Secondary	Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups	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); 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.; Follow up outcome data: mortality and causes of death, incidence of complications.	480 weeks
Secondary	Baseline clinical characteristics MAFLD patients	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.	0 weeks
Secondary	Risk factors for progression to cirrhosis and hepatocellular carcinoma	Risk factors for progression to cirrhosis and hepatocellular carcinoma in MAFLD patients	480 weeks