Metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
Experimental group:In addition to basic lifestyle interventions, patients in this group received oral administration of Partridge Liver-Protecting Pills at a dose of 6g three times daily. Duration: Th
Control group:In addition to basic lifestyle interventions, this group of patients received a placebo. The placebo pills were identical to the Quail-Based Liver Protection Pills in appearance, size, c
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine Hainan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age and Gender: 18–70 years old, no gender restrictions; (2) Liver fat content detected via magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) =5%; (3) Meeting at least one working definition of metabolic syndrome (MetS) component: 1) Overweight/obesity: BMI = 24.0 kg/m², or waist circumference = 90 cm (men) and = 85 cm (women), or excessive body fat content and percentage; 2) Elevated blood pressure/hypertension (systolic blood pressure = 130 mmHg or diastolic blood pressure = 85 mmHg); 3) Prediabetes (fasting blood glucose =6.1 mmol/L, or 2-hour post-glucose load blood glucose =7.8 mmol/L, or HbA1c =5.7%, or HOMA-IR =2.5); 4) Elevated blood triglycerides (fasting serum TG = 1.70 mmol/L) and reduced HDL-C (= 1.0 mmol/L for males, = 1.3 mmol/L for females). (4) If participants have hypertension, stable antihypertensive medication must be maintained for 3 months prior to randomization to achieve stable blood pressure (BP < 140/90 mmHg); (5) Informed consent: Patients voluntarily participate in this clinical study and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Type 2 diabetes mellitus (T2DM); (2) Reaching the intervention threshold for dyslipidemia, requiring lipid-lowering medication that may affect efficacy evaluation metrics: Referencing the Chinese Lipid Management Guidelines (2023 Edition), with LDL-C as the core target, exclude patients meeting any of the following criteria: LDL-C = 4.1 mmol/L, non-HDL-C target level = LDL-C + 0.8 mmol/L, or TG = 5.6 mmol/L; (3) Exclude excessive alcohol consumption (weekly ethanol intake =210 g for males, =140 g for females) and other causes of fatty liver disease, including but not limited to: malnutrition, Wilson's disease, drug-induced liver injury, alcoholic liver disease, autoimmune liver disease, hepatitis B or C virus infection, primary sclerosing cholangitis, etc. (4) Patients with cirrhosis or hepatocellular carcinoma confirmed by liver biopsy or imaging/laboratory indicators; (5) Moderate to severe hepatic dysfunction: ALT and/or AST > 3 times the upper limit of normal (ULN); (6) Renal insufficiency: defined as serum creatinine (Scr) > 1.5×ULN or estimated glomerular filtration rate (eGFR) < 60 mL/min; (7) Other endocrine-related disorders: concomitant thyroid disorders (including hyperthyroidism, hypothyroidism, subclinical hypothyroidism, thyroid carcinoma, etc.), growth hormone deficiency, pituitary dysfunction, etc.; (8) Concurrent severe primary diseases of the lungs, heart, cerebrovascular system, kidneys, hematopoietic system, etc.; (9) Psychiatric disorders: Past or present severe mental illness, including but not limited to schizophrenia, major depressive disorder, substance (e.g., alcohol and drugs) abuse or dependence-related psychiatric disorders, and other psychiatric disorders diagnosed by a psychiatrist as potentially affecting study outcomes or patient safety; (10) Pregnant or lactating women: defined as pregnant or lactating women, and women of childbearing potential who refuse to use investigator-approved contraception throughout the study period; (11) Relative contraindications or restrictions for MRI: Presence of ferromagnetic implants (e.g., pacemakers, ICDs, deep brain stimulators, cochlear implants), claustrophobia, high fever, or thermoregulatory disorders; (12) Participation in other clinical trials within 3 months prior to study enrollment; (13) Inability to adhere to lifestyle intervention measures (diet and exercise protocols) prescribed by the investigator, demonstrating poor compliance; (14) Other circumstances determined by the investigator to render the subject unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in liver fat content after 12 weeks of treatment (i.e., the percentage relative decrease in MRI-PDFF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in liver function: Alanine aminotransferase, Aspartate aminotransferase, Total bilirubin, Total bile acid, Gamma-glutamyl transferase;Changes in blood lipid parameters: Total Cholesterol, Triglycerides, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol, Apolipoprotein A, Apolipoprotein B;Changes in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Levels;Changes in blood glucose indicators: FPG, FPG2h, FINS, HOMA-IR;Anthropometric measurements: height, weight, waist circumference, hip circumference, waist-to-hip ratio, visceral fat index, etc.; | — |
Countries
China
Contacts
Public ContactYaweiCheng
Hainan Hospital, Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed