Type 2 Diabetes
Conditions
Interventions
Experimental Group:Yue Lingfang + Reinforced Lifestyle Intervention
Control Group:Placebo + Intensive Lifestyle Intervention
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and = 65 years, gender; 2. Meet the diagnostic criteria for type 2 diabetes mellitus in Western medicine; 3. Meet the criteria for deficiency of both qi and yin with damp-heat syndrome in Traditional Chinese Medicine; 4. Duration of illness = 5 years; 5. Meet the criteria for 24 kg/m² = BMI = 32.5 kg/m² (or waist circumference: >90 cm for males, >85 cm for females); 6. Fasting C-peptide = 1.1 µg/L; 7. Negative for GADA and other antibodies related to type 1 diabetes; 8. After previous individualized blood glucose control, blood glucose control is achieved, defined as: HbA1c < 6.5% or FPG < 7 mmol/L; (Allowed previous blood glucose control treatments: No drug treatment: blood glucose control through diet and exercise only, meeting blood glucose control standards; Drug treatment: metformin, a-glucosidase inhibitors, SGLT2 inhibitors, insulin, mulberry branch total bioalkali (two or fewer)); 9. The subject understands, agrees to participate in this study, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Disease-related exclusion criteria 1.1 Patients with gestational diabetes or other special types of diabetes; 1.2 Patients with acute complications of diabetes; 1.3 Patients with severe cardiovascular, cerebrovascular diseases, or severe primary diseases of the liver, kidneys, or hematopoietic system; 1.4 Patients with known allergies to the components of the investigational drug or with an allergic constitution; 1.5 Pregnant, breastfeeding women, or those with plans for pregnancy in the near future; 1.6 Patients with long-term alcohol abuse, drug dependence, or mental illness; 1.7 Patients who have participated in or are currently participating in other drug clinical trials within the month prior to the screening period of this study; 1.8 Patients deemed unsuitable for participation in this clinical study by the investigator. 2. Drug use exclusion criteria Current or past use within the last 2 months of long-acting injections, such as weekly GLP-1 receptor agonists or GIP/GLP-1 receptor agonists; current or past use within the last 2 weeks of the following antidiabetic medications: sulfonylureas, glinides, thiazolidinediones, or DPP-4 inhibitors; use of drugs that may interfere with pancreatic function or metabolism (e.g., long-term oral corticosteroids or immunosuppressants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes remission maintenance rate after 12 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| glycated hemoglobin;Fasting Blood Glucose;2-hour postprandial blood glucose;Postprandial C-peptide;Fasting C-peptide;Insulin;Body Mass Index;waist;Waist-Hip Ratio;Waist-to-Height Ratio;Triglyceride;High-Density Lipoprotein;Low-Density Lipoprotein;Total Cholesterol;free fatty acids;Traditional Chinese Medicine (TCM) Syndrome Efficacy Scoring;Diabetes-specific quality of life scale;tumor necrosis factor-alpha;Interleukin-6;High-Sensitivity C-Reactive Protein;Adiponectin;Skin Microcirculatory Perfusion;Transcutaneous oxygen tension; | — |
Countries
China
Contacts
Public ContactYao Zheng
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed