Type 2 diabetes
Conditions
Interventions
Sponsors
Huadong Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) type 2 diabetes; 2) No gender specification, age between 18 and 80 years at the time of signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to GLP-1 receptor agonists; 2) History of heart failure (New York Heart Association class IV), acute coronary syndrome, or cerebrovascular event (excluding old lacunar infarction) within 90 days prior to screening, including but not limited to acute myocardial infarction, unstable angina, stroke/transient ischemic attack, or cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention) within 90 days prior to screening, or severe ECG abnormalities assessed by the investigator, poorly controlled hypertension (defined as systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg) and other cardiovascular and cerebrovascular diseases deemed unsuitable for participation in this trial; 3) Known planned hospitalization for any surgical procedure at the time of screening; 4) Concurrent hyperthyroidism, Cushing’s syndrome, diabetic gastroparesis, or other gastrointestinal emptying disorders (such as pyloric obstruction, intestinal obstruction, postoperative gastroparesis, idiopathic gastroparesis, etc.), gastrointestinal diseases assessed by the investigator as increasing the risk after medication use (such as severe active ulcer, inflammatory bowel disease, gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.), anorexia, alcohol dependence, drug abuse, drug dependence, epilepsy, psychiatric disorders, requiring systemic anti-infective treatment, or other conditions assessed by the investigator as affecting endpoint evaluation; 5) Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2); 6) History of chronic or acute pancreatitis; 7) Repeated occurrences (>=3 times) of grade 3 hypoglycemic events within 90 days prior to screening; 8) History of acute metabolic complications (ketosis, lactic acidosis, or hyperosmolar hyperglycemic syndrome) within 180 days prior to screening; 9) Diagnosis of malignant tumor within 5 years prior to screening (excluding adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally excised prostate cancer, and excised ductal carcinoma in situ of the breast); 10) Pregnant or lactating women, individuals planning to conceive during the study, or females or males who do not agree to use effective contraceptive methods; 11) As judged by the investigator, the subject has any disease or condition that may compromise their safety or affect compliance with the study protocol, or other conditions deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin;gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| anthropometric indicators;glucose parameters;lipid profiles;liver and renal function;multi-omics parameters;cytokines;islet function;Gastrointestinal Function ; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huadong Hospital Affiliated to Fudan University
Outcome results
None listed