Clinical Characteristics of Metabolic Associated Fatty Li... | NCT06325254

NCT06325254

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Name	Role	Phone	Extension	Email
Jie Li, M.D.,Ph.D	Contact	15863787910		lijier@nju.edu.cn
Qianqian Chen	Contact	18360722012		qian_1395692197@126.com