polycystic ovarian syndrome
Conditions
Interventions
Semaglutide group:Semaglutide combined with basic treatment
Metformin group:Metformin combined with basic treatment
Sponsors
The First Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.PCOS as diagnosed by Chinese criteria; 2.BMI >= 24 kg/m2; 3.Aged 18-45 years; 4.Informed written consent.
Exclusion criteria
Exclusion criteria: 1. The patient was diagnosed as medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or had a family history of the above diseases. The endocrinologist found a family history of medullary thyroid carcinoma or thyroid nodule when screening; 2. Use drugs known to affect insulin sensitivity: metformin (not used within 3 months before screening), oral glucocorticoids, atypical antipsychotics, immunosuppressants, HIV drugs, hormonal contraception (not used within 6 months before screening) within 10 days, skin patches or vaginal rings. Weight loss drugs or stimulants. Use other products containing other GLP-1 agonists; 3. Pregnant or lactating women. The development of pregnancy during the study period will require withdrawal from the study; 4. Serious illness, requiring hospitalization within 60 days; 5. Diabetic patients (according to the WHO diagnostic criteria for diabetes in 1999); 6. Anemia, hemoglobin less than 110g/L; 7. Major mental illness or developmental disorder with limited informed consent diagnosed; 8. Antihypertensive drugs are being used; 9. eGFR < 45ml/min/1.73m2 in case of any known serious kidney disease or screening; 10. Have a history of serious gastrointestinal diseases (such as gastroparesis); 11. Have a history of gallstone; 12. Have untreated thyroid disease; 13. Allergies to any component of the study drug: smeglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide; 14. Hyperandrogen with other causes (such as tumor, congenital adrenal hyperplasia) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma); 15. Anorexia nervosa or bulimia nervosa that is active or under treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight;body mass index;waist circumference; | — |
Secondary
| Measure | Time frame |
|---|---|
| sex hormone;sex hormone binding globulin;homeostasis model assessment of insulin resistance;inflammatory factor;visceral adipose tissue area; | — |
Countries
China
Contacts
Public ContactHaifeng Wang
The First Affiliated Hospital of Hainan Medical University
Outcome results
None listed