newly-diagnosed overweight / obesity type 2 diabetes mellitus
Conditions
Interventions
Placebo Group: metformin
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. HbA1c 7 to 9%; 3. The newly-diagnosed type 2 diabetes and was accompanied by overweight/ obesity, and the course of disease less than 2 years; 4. Those who controlled blood glucose only through diet or exercise, or only one oral hypoglycemic drug (except GLP-1 receptor agonist metformin) and failed to take hypoglycemic drugs regularly in the last 3 months; 5. Understand and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Except for other types of diabetes (type 1 diabetes, secondary diabetes and gestational diabetes); 2. Overweight/obesity caused by Cushing/Cushing syndrome and other endocrine system diseases; 3. Patients with clinically obvious hepatobiliary diseases, including, but not limited to,chronic active hepatitis and /or severe liver dysfunction, liver cirrhosis. Glutamic-pyruvic transaminase (ALT) or glutamic oxaloacetic transaminase (AST)>3 times normal upper limit (150U/L) or serum total bilirubin (TB)> 34.2 umol/L(>2mg/dL); 4. Patients with the following renal history or kidney disease related characteristics: (1) Unstable or rapid progressive renal history; (2) patients with moderate/severe renal injury or end-stage kidney disease: (eGFR) 1800 mg/g; (4) the serum Cr of male subjects was >=133 umol/L ( 1.40mg/dL); 5. any of the following cardiovascular diseases occurred in the past 6 months: (1) myocardial infarction; (2) Heart surgery or revascularization (coronary artery bypass grafting / transluminal coronary angioplasty); (3) unstable angina pectoris; (4) congestive heart failure (New York Heart Society grade III or IV); (5) transient ischemic attack or significant cerebrovascular disease; 6. complicated with malignant tumors, multiple organ dysfunction and other chronic consumptive diseases; 7. The history of operation or severe trauma in the last 3 months; 8. known immunocompromised states, including, but not limited to, individuals undergoing organ transplantation or acquired immunodeficiency syndrome (AIDS); 9. The blood collected or donated blood products, blood transfusions or participating clinical studies in the last 30 days require the blood to be withdrawn> 400 mL; 10. use any other test drug within nearly 30 days or within 5 half-lives of other experimental drugs; 11. Pregnancy or lactating women and planned pregnancy throughout the trial; 12. unable to cooperate with mental symptoms; 13. the whole clinical study could not be coordinated and completed due to other factors; 14. Persons previously diagnosed with hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting C-peptide (FC-P), insulin, HOMA-IR, carotid intimal ultrasound, blood lipid spectrum, liver and kidney function markers, HC,WC, coronary heart disease risk prediction score, quality of life score; | — |
Countries
China
Contacts
Public ContactXiaoming Chen
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed