Polycystic Ovary Syndrome
Conditions
Brief summary
To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.
Interventions
DRUGMetformin
Use Metformin for 3 months to treat PCOS
DRUGExenatide
Use Exenatide for 3 months to treat PCOS
Sponsors
Bing He
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria 2. Overweight/obesity (BMI≥24 kg/m2) 3. No pregnant plan in recent 6 months 4. Written consent for participation in the study
Exclusion criteria
1. type 1 or type 2 diabetes mellitus 2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia 3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 4. Serious systemic disease or malignant tumor 5. History of pancreatitis (chronic, acute or recurrent) 6. Body weight change ≥10% at 3 months before treatment 7. Used oral contraceptives or sex hormone drugs in the past 1 month 8. Used oral glucocorticoids in the past 1 month 9. Substance (alcohol or drug) abuse or dependence within 3 months 10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d) 11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR\<60ml/min/1.73m2) 12. Increase of transaminases up to \< 2.5 times of upper limit of normal value 13. Have a history of thromboembolic disease or thrombotic tendency 14. Subjects in pregnant or lactating or within 1 year after delivery 15. Subjects have an allergic history to the drugs used in the study 16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization 17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | 12 weeks | Change in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference(WC) | 12 weeks | Change in waist circumference(WC) |
| Change in Ferriman-Gallwey score | 12 weeks | Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome. |
| Change in Acne severity score | 12 weeks | Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome. |
| Changes in frequency of menstrual cycle | 12 weeks | Changes in frequency of menstrual cycle |
| Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) | 12 weeks | glucose obtained at 0,30,60 and 120 minutes during the OGTT. |
| Changes in Luteinizing Hormone (LH) | 12 weeks | Changes in Luteinizing Hormone (LH) |
| Changes in follicle stimulating hormone (FSH) | 12 weeks | Changes in follicle stimulating hormone (FSH) |
| Changes in LH/FSH | 12 weeks | Changes in LH/FSH |
| Change in body mass index (BMI) | 12 weeks | Change in body mass index (BMI) |
| Changes in progesterone (Prog) | 12 weeks | Changes in progesterone (Prog) |
| Changes in total testosterone (TT) | 12 weeks | Changes in total testosterone (TT) |
| Changes in free testosterone (FT) | 12 weeks | Changes in free testosterone (FT) |
| Changes in free androgen index (FAI) | 12 weeks | Changes in free androgen index (FAI) |
| Changes in sex hormone binding globulin (SHBG) | 12 weeks | Changes in sex hormone binding globulin (SHBG) |
| Changes in dehydroepiandrosterone sulfate (DHEAS) | 12 weeks | Changes in dehydroepiandrosterone sulfate (DHEAS) |
| Changes in anti-müllerian hormone (AMH) | 12 weeks | Changes in anti-müllerian hormone (AMH) |
| Changes in prolactin (PRL) | 12 weeks | Changes in prolactin (PRL) |
Countries
China
Outcome results
None listed