A prospective cohort study of real-world clinical diagnosis and treatment of metabolic related fatty liver disease (MAFLD)

Not Applicable

• Conditions: metabolic associated fatty liver disease, MAFLD

• Registration Number: ITMCTR2200006552
• Lead Sponsor: Hubei Provincial Hospital of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnostic criteria
The diagnosis of MAFLD[1] is based on hepatic steatosis (detected by liver histology, imaging, or non-invasive biomarkers) and the presence of at least one of the following three criteria, including:
(1) Overweight or obese;
(2) Type 2 diabetes (T2DM);
(3) There are at least two risk factors for abnormal metabolism:
a. Waist circumference: Asian men = 90cm, women = 80cm
b. Blood pressure: =130/85mmHg or receive specific drug treatment
c. Triglyceride: =1.7mmol/L or receive specific drug treatment
d. High-density lipoprotein cholesterol: male <1.0 female <1.3mmol/L or receiving specific drug treatment
e. Pre-diabetes: fasting blood glucose 5.6~6.9mmol/L or postprandial blood glucose 7.8~11.0mmol/L or glycosylated hemoglobin 5.7~6.4%
f. Homeostasis Model Assessment - Insulin Resistance Index: HOMA-IR=2.5
g. Blood high-sensitivity C-reactive protein: CRP>2mg/L
2. Inclusion criteria
1) Age: 10-65 years old, gender is not limited;
2) Meet the above diagnostic criteria for metabolic-associated fatty liver disease (MAFLD);
3) Good compliance, willing to abide by the principle of follow-up;
4) Agree to sign the informed consent;
5) Only those who meet all the above conditions can participate in this study.

Exclusion Criteria

Exclusion criteria
1) Serious diseases of the heart, liver, lung, kidney, brain, blood, neuropsychiatric system, etc., whose disease is not under control;
2) Diagnose patients with liver fibrosis, liver cirrhosis, alcoholic liver disease, immune liver disease and drug-induced liver disease;
3) Patients with various malignant tumors;
4) Patients who have received fatty liver related diagnosis and treatment within 1 month;
5) Pregnant or lactating women;
6) The researcher believes that it is not suitable to participate in this research;
Anyone who meets any of the above criteria cannot participate in this study.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SM;ALT;PLT;AST;Liver histopathology score;

Secondary Outcome Measures

Name	Time	Method
FBG;INS;CEA;