Type 2 Diabetes Mellitus accompanied with Metabolic Dysfunction-Associated Fatty Liver Disease
Conditions
Interventions
Control group:Standardized lifestyle guidance
Test Group:CGM wearing and artificial intelligence technology support
Sponsors
Beijing Friendship Hospital Pinggu Campus,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 70 years old; 2. Clinically diagnosed with T2DM according to the classification of the World Health Organization or other applicable local diagnostic criteria; 3. Meets the diagnostic criteria of the "Metabolic Associated (Non-alcoholic) Fatty Liver Disease Prevention and Treatment Guidelines (2024 Edition)" in China, with the CAP value of FibroScan examination >= 248 dB/m; 4. HbA1c: >= 6.5% to <= 9.0% (within 3 months before enrollment); 5. Willing to wear CGM and cooperate with the intervention; 6. Capable of operating a smartphone (iOS/Android system), and able to use the APP independently; 7. Voluntarily participate in the study and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. During the screening, if there was a history of acute diabetic complications within the previous 1 year (including diabetic ketoacidosis, hyperosmolar hyperglycemic state, as well as severe hypoglycemia or unperceived hypoglycemia); 2. Screening for excessive alcohol consumption within the past 3 months (alcohol intake for men >= 210g per week and for women >= 140g per week); 3. During the screening process, the LSM value of FibroScan was >= 17.5 kPa; 4. Previous history of chronic liver disease (caused by viral factors, autoimmune factors, or drug-induced damage), or severe liver function impairment (with ALT or AST levels higher than three times the upper limit of normal); 5. Having diabetes-related chronic complications and the researcher deeming it inappropriate to undergo exercise intervention; 6. Severe comorbidities: Suffered from myocardial infarction within 6 months, uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure >= 90 mmHg), chronic heart failure (NYHA classification grade 3 or above), severe renal dysfunction (eGFR < 45 ml/min/1.73m²); 7. Pregnancy, lactation or planned pregnancy; 8. Mental illness or cognitive impairment cannot be accommodated; 9. Participate in the weight loss research project within three months; 10. Currently participating in other clinical trials; 11. Currently using drugs that affect movement; 12. History of chronic diarrhea or intestinal diseases; 13. Has a history of drug abuse; 14. Expected lifespan < 1 year; 15. Any other researchers who deemed the patients unsuitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver steatosis CAP value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Stiffness Measurement;Blood glucose control indicators (HbA1c, TIR, TAR, TBR, MAGE, FPG, 2h-PG); | — |
Countries
China
Contacts
Public ContactYufeng Li
Beijing Friendship Hospital Pinggu Campus,Capital Medical University
Outcome results
None listed