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This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin.
The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin-Placebo | Experimental | Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo |
|
| Placebo-metformin | Placebo Comparator | Placebo tablets, 2x 2 tablets per day for 12 weeks, 6 weeks wash-out, 12 weeks metformin, 2x 2 tablets per day, 500 mg per tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin, 2x 2 tablets a day, 500 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in incretin effect from baseline and until after removal of insulin resistance | The incretin effect will be assessed from the insulin secretion during af 75 g OGTT and IIGI at baseline and after 12 weeks' treatment with placebo and metformin | baseline and 12 weeks' treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon response | Glucagon responses (plasma concentrations) will be assessed during the 75-g OGTTs | 0, 12 and 30 weeks |
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Inclusion Criteria PCOS-women:
Inclusion Criteria healthy women:
Exclusion Criteria PCOS and healthy women:
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| Name | Affiliation | Role |
|---|---|---|
| Louise Vedtofte, MSc., PhD | University Hospital, Gentofte, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Gentofte | Hellerup | Select A State | 2900 | Denmark |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo (to metformin) |
|
| 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 |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |