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Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMBO (sitagliptin and metformin) | Experimental | metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks |
|
| MET (metformin) | Experimental | metformin 1000 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin and metformin | Drug |
|
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight. | Patient's body weight was measured at the baseline and after 12 weeks of clinical trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass indey (BMI). | The BMI was calculated as the body mass divided by the square of the body height (kg/m2) | Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrej Janež, MD PhD | University Medical Centre Ljubljana | Principal Investigator |
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| Drug |
|
|
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D001835 | Body Weight |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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