Clinical Characteristics of Metabolic Associated Fatty Liver Disease

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

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 Overview

• Status: Recruiting
• Conditions: Metabolic Associated Fatty Liver Disease; Clinical Features

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Jie Li, M.D.,Ph.D; Phone Number: 15863787910; Email: lijier@nju.edu.cn
• Study Contact Backup: Name: Qianqian Chen; Phone Number: 18360722012; Email: qian_1395692197@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Jie Li, M.D.,Ph.D; Phone Number: 15863787910; Email: lijier@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MAFLD patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Risk factors for progression to cirrhosis and hepatocellular carcinoma	Risk factors for progression to cirrhosis and hepatocellular carcinoma in MAFLD patients	480 weeks

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic associated fatty liver disease; Clinical features
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: MAFLD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No