Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age between 18-80 years, gender; (2) All are newly diagnosed with diabetes and have not used any oral hypoglycemic drugs or combined treatment regimens (including compound formulations) or insulin before enrollment; (3) Patients with type 2 diabetes, with HbA1c ranging from 9% to 11%; (4) Syndrome differentiation belongs to qi deficiency type; (5) Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) T1DM, gestational diabetes, and other specific types of diabetes; (2) History of acute diabetic complications (including diabetic hypoglycemia, diabetic hyperosmolar coma, etc.); (3) Significant impairment of heart, liver, or kidney functions; (4) Use of antibiotics, probiotics, or microecological live bacterial preparations within the past 1 month; (5) Have experienced =1 severe hypoglycemic episode in the past 6 months or recurrent hypoglycemic events in the past 1 month; (6) History of gastrointestinal surgery or irritable bowel syndrome; (7) Patients with mental illness; (8) Individuals with a history of allergies; (9) Anticipated significant lifestyle changes (e.g., working night shifts) or major dietary changes during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glucagon-like PePtide-1;gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gender;Age;disease course;Weight;Fasting Plasma glucose;Two-hour PostPrandial blood-glucose;Glycosylated hemoglobin;Fasting insulin;Fasting C-PePtide ;Traditional Chinese Medicine Syndrome Scoring; | — |
Countries
China
Contacts
Shanghai University of Traditional Chinese Medicine Affiliated Putuo Hospital