HBV infection complicated with MAFLD
Conditions
Interventions
Observation group:None
Control group:None
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, BMI > 24kg/m^2, CAP > 248, regardless of gender; 2. The diagnosis of CHB was in accordance with the "Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition)" : HBsAg positive >=6 months, or a clear history of hepatitis B; 3. Chronic hepatitis B: initial treatment with nucleoside analogue combined with semaglutide; Treated patients: who were receiving ETV/TDF/TAF/TMF treatment for >=6 months, and HBV DNA was persistently below the lower limit of detection (=248 dB/m and presence of at least one metabolic risk factor). 5. Provide written informed consent. 6. The patient was willing to accept medical treatment and follow-up.
Exclusion criteria
Exclusion criteria: (1) Chronic liver disease other than CHB and MAFLD (including but not limited to alcohol or drug abuse, drugs or poisons, other viral hepatitis such as chronic hepatitis C, autoimmunity, hemochromatosis, Wilson's disease, a1-antitrypsin deficiency); (2) any clinical evidence or history of previous or existing liver cirrhosis (F4) and a history of decompensated cirrhosis (ascites, spontaneous bacterial peritonitis, variceal bleeding, or hepatic encephalopathy); In the absence of histologic findings, cirrhosis was defined as: 1) LSM-VCTE>=20 kPa; 2) LSM-VCTE>=15 kPa and =10 kPa and 20 ng/mL at screening; (b) total bilirubin > 2 times upper limit of the normal range (ULN); (c) serum alanine aminotransferase (ALT) > 5×ULN (d) serum aspartate aminotransferase (AST) > 5×ULN; Alkaline phosphatase (ALP) > 2×ULN; (f) albumin 1.3; (h) HbA1c > 9.5%; (i) platelet count 1 year before the screening period or the entry time point in the screening period: a) liposuction and/or abdominoplasty; b) gastric banding (if the band has been removed); c) intragastric water balloon (if it has been removed); Or d) duodenojejunal bypass cuff (if the cannula has been removed); (13) weight change > 5% within 6 months before the screening period; (14) have obesity induced by other endocrine disorders (including but not limited to Cushing's syndrome) or diagnosed as monogenic or syndrom obesity (including but not limited to melanocortin-4 receptor deficiency, leptin deficiency, or Prader-Willey syndrome); (15) history of any type of diabetes except type 2 diabetes mellitus (T
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter;Blood sugar level;Blood lipid levels;Liver function;Body mass index, BMI;MRI-PDFF;Quality of life assessment;Magnetic resonance elastography, MRE; | — |
Countries
China
Contacts
Public ContactFeng Ye
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed