Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged between 20 and 75 years old (including boundaries); 2. Meet the diagnostic criteria for healthy individuals; 3. Meet the diagnostic criteria of prediabetes; 4. Meet the diagnostic criteria of type 2 diabetes.
Exclusion criteria
Exclusion criteria: 1. Patients with other types of diabetes mellitus rather than T2DM. 2. Those with severe combined diabetic complications such as diabetic ketoacidosis hyperosmolar hyperglycemic syndrome or lactic acidosis. 3. Patients with clinically significant hepatobiliary disease including but not limited to chronic active hepatitis and/or severe hepatic insufficiency cirrhosis glutamic aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) > 3 times the upper limit of normal (150 U/L) or serum total bilirubin (TB) > 34.2 µmol/L (>2 mg/dL). 4. Patients with the following history of renal disease or features associated with renal disease: history of unstable or rapidly progressive renal disease patients with moderate/severe renal impairment or end-stage renal disease glomerular filtration rate estimate (eGFR) 1.40 mg/dl) in female subjects. 5. Any of the following cardiovascular conditions: myocardial infarction cerebral infarction cardiac surgery or revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty) unstable angina congestive heart failure (New York Heart Association class III or IV) transient ischemic attack or significant cerebrovascular disease within the last 12 weeks. 6. History of gastrointestinal disease or surgery including intestinal obstruction intestinal ulcer bariatric surgery or girdle surgery gastrointestinal anastomosis or bowel resection. 7. Pregnant women who were breastfeeding. 8. Urinary tract infection within the last 2 weeks. 9. Patients who have taken antibiotics probiotics or gastrointestinal motility medications in the past month. 10. Those who have not signed the informed consent form. 11. Subjects who are in the judgment of the investigator unlikely to comply with the protocol or patients with serious physical or psychological illnesses that could affect the effectiveness or safety of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-hour postprandial blood glucose;Fasting blood glucose;glycosylated hemoglobin;Blood metabolomics;Constitution in Chinese Medicine Questionnaire;Blood proteomics;gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase;Uric acid;Serum creatinine;High density lipoprotein cholesterol;Thyroid stimulating hormone;Total cholesterol;urine metabolism;Fasting insulin;Aspartate aminotransferase;triglyceride;blood routine examination;Low density lipoprotein cholesterol; | — |
Countries
China
Contacts
The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University