Type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease
Conditions
Interventions
JTTG group:JTTG formula will be administered alongside lifestyle interventions.
Control group:Placebo formula will be administered alongside lifestyle interventions, with the same dosage and usage as JTTG formula.
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Body Mass Index (BMI) >= 24 kg/m^2; 3. Newly diagnosed T2DM patients (2025 American Diabetes Association diagnostic criteria: typical symptoms with HbA1c >= 6.5%, fasting blood glucose >= 7.0 mmol/L, 2-hour postprandial blood glucose >= 11.1 mmol/L, or random blood glucose >= 11.1 mmol/L); 4. Clinically diagnosed MASLD (2023 MASLD Multi-Society Delphi Consensus diagnostic criteria: based on imaging or hepatic histology showing liver steatosis, plus any one of five metabolic criteria including overweight/obesity, T2DM, hypertension, reduced HDL cholesterol levels, or elevated plasma triglyceride levels); 5. Traditional Chinese Medicine syndrome type: 'Internal Damp-Heat'; 6. Glycated hemoglobin (HbA1c) = 11%; MRE measured LSM value >= 3.14 kPa; 8. Voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with non-type 2 diabetes mellitus (such as: type 1 diabetes, gestational diabetes, etc.); 2. Liver disease caused by other non-metabolic factors such as autoimmune liver disease, viral liver disease, alcoholic liver disease, etc.; 3. Alcohol intake: 20 g/day > women, 30 g/day > men; 4. LSM value measured by MRE >=4.45kPa, decompensated cirrhosis, liver cancer; 5. Combined with serious primary diseases such as cardiovascular, renal and hematopoietic system and other extrahepatic tumors; 6. Three times the upper limit of normal = the of the upper limit of normal for the of the glomerular filtration rate, or the <> of total bilirubin = 1.5 times the upper limit of the normal value; 7. Patients with diabetes-related serious complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome) and excessive weight loss (>=10kg) in the past 3 months; 8. Systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg, and those who have not been stably using antihypertensive and lipid-lowering drugs (such as drug types, specifications and dosage forms) in the past 6 months or drugs that can cause hepatic steatosis (such as amiodarone, tamoxifen, methotrexate, glucocorticoids, etc.); 9. Pregnant (or planning to become pregnant) and lactating women, or women of childbearing potential but unable to achieve effective contraceptive measures; 10. Patients who are allergic to traditional Chinese medicine; 11. Stomach ulcers, irritable bowel syndrome, or chronic diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver stiffness measurement (LSM) ;Low-density lipoprotein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin;Fasting plasma glucose;2h oral glucose tolerance test;Random blood glucose;Fasting insulin;High-density lipoprotein;Triglyceride;Cholesterol;Alanine aminotransaminase;Aspartate aminotransaminase;C-peptide;Total bilirubin;Direct bilirubin;?-glutamyl transpeptidase;Albumin;Weight;Waist-to-hip ratio;Pancreatic stiffness value;Blood pressure;Proton density fat fraction;Waist circumference; | — |
Countries
China
Contacts
Public ContactXiaolong Qi
Zhongda Hospital Southeast University
Outcome results
None listed