Polycystic ovary syndrome, Overweight/obesity
Conditions
Interventions
Efsubaglutide a group:Efsubaglutide a 3 mg by subcutaneous injection once weekly
Efsubaglutide a with dietary fiber group:Efsubaglutide a 3 mg by subcutaneous injection once weekly, combined with supplementary dietary fiber of 45 g per day.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnosed with PCOS according to the Rotterdam criteria; 2.BMI >=24kg/m^2; 3.Age 18 - premenopausal; 4.No participate in any other research projects; 5.Sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Combined with ovarian or adrenal tumors that produce androgens; combined with Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia, and other diseases that cause excessive androgen production and anovulation; history of insulin sensitizer, corticosteroid, and sex hormone treatment within 3 months. 2.Individuals who have undergone weight loss through any pharmacological method (including appetite suppressants such as fluphenazine and other weight loss drugs) or surgical procedure within the past three months. 3.Excessive drinking (drinking Baijiu more than 5 times a week, with an average of 100 grams of Baijiu or 250 grams of yellow wine or more than 5 bottles of beer per occasion); 4.Received medication for the following diseases within the past 3 months: peptic ulcer, cholecystitis, gallstones, urinary tract infection, acute pyelonephritis, cystitis; 5.Have undergone gastrointestinal surgery within the past year, excluding appendicitis and hernia surgery; 6.Patients with chronic and persistent hepatitis, severe liver diseases such as cirrhosis, and those with abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase levels are 2.5 times higher than normal); 7.Suffering from digestive tract ulcers, acute or chronic renal insufficiency, uremia; gallstones; severe organic diseases such as tumors/cancer, coronary heart disease, myocardial infarction, and stroke, etc; 8.Suffering from infectious diseases such as tuberculosis and AIDS; epilepsy; congenital heart disease; systemic lupus erythematosus; 9.Aplastic anemia, primary thrombocytopenic purpura, anemia (hemoglobin <10g/dl); 10.Suffered from severe mental illness within the past 6 months; 11.Cannot guarantee sufficient time to participate in this project; pregnant or unable to ensure contraception during the intervention period and for one month after the end of follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of weight loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in free androgen index (FAI);Changes in HOMA-IR;Changes in Triglyceride;Changes in waist circumference;Changes in fasting blood glucose;Gastrointestinal adverse event rate;Changes in HDL;Change in muscle mass;Changes in gut microbiota composition;Change in fat mass;Changes in Modified Polycystic Ovary Syndrome Questionnaire (MPCOSQ) scores;Changes in hip circumference;Changes in total cholesterol;Changes in neurotransmitters;Changes in waist/hip ratio;Changes in HbA1c;Changes in LDL; | — |
Countries
China
Contacts
Public ContactMa Yuhang; Ding Xiaoying
Shanghai General Hospital
Outcome results
None listed