Type 2 Diabetes Mellitus
Conditions
Interventions
Focused Ultrasound Stimulation Group:Enrolled patients will receive focused ultrasound stimulation targeting the hepatic hilar nerve plexus. The treatment will be administered once daily for 15 minute
Sham Stimulation Group:The sham stimulation group will undergo identical procedures at the same anatomical site as the focused ultrasound treatment group, but without the delivery of actual ultrasound
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of Type 2 Diabetes Mellitus for >= 1 year, Aged 21 to 75 years, BMI between 18 and 35 kg/m²; 2. HbA1c levels between 7.5% and 9.5%, Treated with metformin monotherapy only for >= 3 months; 3. The perihilar structures can be clearly visualized via ultrasound. 4. Stable clinical condition with normal laboratory findings and ECG results; capable of complying with follow-up and monitoring. 5. Patients voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Insulin-dependent diabetes mellitus (Type 1 diabetes mellitus); 2. Current use of insulin or other injectable therapies; 3. High-risk populations (e.g., those with severe diabetic complications, hepatic or renal dysfunction, or cardiovascular and cerebrovascular diseases); 4. Diseases of the biliary system; 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose, FPG;Homeostasis Model Assessment of Insulin Resistance, HOMA-IR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1,5-Anhydroglucitol;Glycated Albumin;Incidence of Adverse Events; | — |
Countries
China
Contacts
Public ContactYun Liu
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed