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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin (BMI<24) | Active Comparator | Subjects: PCOS patients whoseBMI<24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months |
|
| Metformin (BMI≥24) | Experimental | Subjects: PCOS patients whoseBMI≥24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months |
|
| Combination (BMI<24) | Experimental | Subjects: PCOS patients whoseBMI<24 Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months |
|
| Combination (BMI≥24) | Experimental | Subjects: PCOS patients whoseBMI≥24 Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Use Metformin for 3 months to treat PCOS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change in body weight | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) | Change in body mass index (BMI) | 12 weeks |
| Change in waist circumference(WC) | Change in waist circumference(WC) |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
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| Exenatide | Drug | Use Exenatide for 3 months to treat PCOS |
|
| 12 weeks |
| Change in Ferriman-Gallwey score | Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome. | 12 weeks |
| Change in Acne severity score | Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome. | 12 weeks |
| Changes in frequency of menstrual cycle | Changes in frequency of menstrual cycle | 12 weeks |
| Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) | glucose obtained at 0,30,60 and 120 minutes during the OGTT. | 12 weeks |
| Changes in Luteinizing Hormone (LH) | Changes in Luteinizing Hormone (LH) | 12 weeks |
| Changes in follicle stimulating hormone (FSH) | Changes in follicle stimulating hormone (FSH) | 12 weeks |
| Changes in LH/FSH | Changes in LH/FSH | 12 weeks |
| Changes in prolactin (PRL) | Changes in prolactin (PRL) | 12 weeks |
| Changes in progesterone (Prog) | Changes in progesterone (Prog) | 12 weeks |
| Changes in total testosterone (TT) | Changes in total testosterone (TT) | 12 weeks |
| Changes in free testosterone (FT) | Changes in free testosterone (FT) | 12 weeks |
| Changes in free androgen index (FAI) | Changes in free androgen index (FAI) | 12 weeks |
| Changes in sex hormone binding globulin (SHBG) | Changes in sex hormone binding globulin (SHBG) | 12 weeks |
| Changes in dehydroepiandrosterone sulfate (DHEAS) | Changes in dehydroepiandrosterone sulfate (DHEAS) | 12 weeks |
| Changes in anti-müllerian hormone (AMH) | Changes in anti-müllerian hormone (AMH) | 12 weeks |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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