Disordered carbohydrate metabolism
Conditions
Interventions
Metformin treatment group:Basic treatment for diabetes combined with metformin extended-release tablets (National Drug Approval No. H20031104, 500mg/tablet), 500 mg twice daily, taken after breakfast
Shenling Baizhu Powder Treatment Group:Basic treatment for diabetes combined with Shenling Baizhu Powder decoction (referencing *Dictionary of Chinese Medicine Formulas*, ingredients include: 10g of g
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine (University Town Endocrinology Department)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Adults aged between 18-70 years, regardless of gender; (2) Patients with and BMI =24 kg/m², who meet the diagnostic criteria for prediabetes or diabetes and the TCM syndrome differentiation criteria; (Prediabetes diagnostic criteria: (refer to WHO 1999 and ADA 2022 prediabetes diagnostic criteria) random or 2-hour post-glucose load blood glucose =7.8 mmol/L, <11.1 mmol/L, or fasting blood glucose =6.1 mmol/L, <7.0 mmol/L; and/or glycated hemoglobin =5.7%, <6.5%. Diabetes diagnostic criteria: random or 2-hour post-glucose load blood glucose =11.1 mmol/L, or fasting blood glucose =7.0 mmol/L; and/or glycated hemoglobin =6.5%. TCM spleen deficiency with dampness obstruction type diabetes diagnostic criteria: obesity, edema, fatigue, heaviness in limbs, abdominal distension with poor appetite, reduced urination, pale and enlarged tongue with white greasy coating, and slow or moderate pulse. (National Administration of Traditional Chinese Medicine, Department of Medical Affairs, TCM Disease Diagnostic and Efficacy Criteria, 2017).) (3) No history of weight loss treatment within the past month (excluding diet and exercise); (4) Good compliance, able to effectively cooperate with dietary adjustments, exercise, treatment plans, and clinical examinations (judged after communication with the patient and their family); (5) Complete past medical records and laboratory test data; (6) All participants are fully informed and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Secondary obesity caused by endocrine diseases or other conditions; (2) Individuals with type 1 diabetes; (3) Pregnant or breastfeeding women; (4) Individuals with primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems; (5) Individuals with severe mental disorders, such as schizophrenia, depression, or anxiety; (6) Individuals with diseases affecting metabolic indicators, such as Cushing's syndrome, prolactinoma, or systemic lupus erythematosus; (7) Individuals with infectious diseases; (8) Individuals currently using medications that affect insulin secretion or carbohydrate and lipid metabolism; (9) Individuals with a history of gastrointestinal diseases; (10) Individuals with missing critical information in their medical records that cannot be supplemented; (11) Individuals allergic to metformin or Shenling Baizhu powder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index;Waist-Hip Ratio;Glucagon-like peptide-1;Glucose-dependent insulinotropic peptide;Fasting Blood Glucose;Fasting Insulin;Fasting C-peptide;Total Cholesterol;Triglyceride;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;Tumor Necrosis Factor-alpha;Interleukin-6;Interleukin-1 beta;Metabolomics;Transcriptomics;Gut microbiota examination;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactWei Song
Guangdong Provincial Hospital of Traditional Chinese Medicine (University Town Endocrinology Department)
Outcome results
None listed