Clinical Characteristics of Metabolic Associated Fatty Liver Disease

NCT06325254 | Recruiting

• 1 other identifier: MAFLD
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Associated Fatty Liver Disease; Clinical Features

Keywords

Metabolic associated fatty liver disease; Clinical features

Outcome Measures

Primary Outcomes (1)

• Clinical characteristics and follow-up outcomes of MAFLD patients

  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).

  480 weeks

Secondary Outcomes (3)

• Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups

  480 weeks

• Baseline clinical characteristics MAFLD patients

  0 weeks

• Risk factors for progression to cirrhosis and hepatocellular carcinoma

  480 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MAFLD patients

You may qualify if:

• years or older;
• MAFLD patients

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Central Study Contacts

Jie Li, M.D.,Ph.D

CONTACT

15863787910; lijier@nju.edu.cn

Qianqian Chen

CONTACT

18360722012; qian_1395692197@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: January 1, 2010
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CN (1)