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The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin (Participants will receive dapagliflozin 10mg po qd). |
|
| Placebo | Placebo Comparator | Placebo (Participants will receive placebo po qd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in insulin resistance over 12 weeks | Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR) | Baseline and 12 weeks |
| Improvement in serum androgen level over 12 weeks | Change in androgen level assessed by free testosterone index(FAI) | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT) | Baseline to 12 week | |
| Change in serum free testosterone(FT) | Baseline to 12 week | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Drug | Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education. |
|
| Change in serum sex hormone binding globulin(SHBG) |
| Baseline to 12 week |
| Net change in total testosterone (TT) level | Baseline and 12 weeks |
| Net change in dehydroepiandrosterone-sulfate(DHEAS) level | Baseline and 12 weeks |
| Net change in androstenedione(AD) level | Baseline and 12 weeks |
| Net change in luteinzing hormone(LH) level | Baseline and 12 weeks |
| Net change in waist circumference | Baseline to 12 week |
| Net Change in liver fat | Liver fat will be assessed by liver fibroscan. | Baseline to 12 week |
| Change in ovulation rate assessed by serum progesterone | Baseline to 12 week |
| Net change in body weight | Baseline to 12 week |
| Net change in BMI | Baseline to 12 week |
| Net change in glucose | Baseline to 12 week |
| 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 |