Status:
COMPLETED
Incretin Effect in PCOS Women
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
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 ins...
Eligibility Criteria
Inclusion
- Inclusion Criteria PCOS-women:
- Diagnosed with PCOS according to the Rotterdam criteria
- more than 18 years old
- BMI less than 30 kg/m2
- Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
- Negative GAD65 and islet cell autoantibodies
- Insulin resistant according to HOMA-IR
- informed consent
- Inclusion Criteria healthy women:
- more than 18 years old
- BMI less than 30 kg/m2
- Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
- Negative GAD65 and islet cell autoantibodies
- informed consent
- regular menstrual cycle (28-35 days)
- Plasma androgen levels within reference levels
- Exclusion Criteria PCOS and healthy women:
- First or second degree relatives with diabetes
- pregnancy or breast feeding
- treatment with medication which influences the glucose metabolism (incl hormonal contraception)
- Congenital diseases which cause hyperandrogenism and irregular bleeding
- Known adrenal hyperplasia
- Known hyperprolaktinemia
- Alcohol consumption of more than 20 grams a day
- Hemoglobin less than 7.8 %
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01892254
Start Date
June 1 2013
End Date
November 23 2017
Last Update
November 27 2020
Active Locations (1)
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1
Copenhagen University Hospital Gentofte
Hellerup, Select A State, Denmark, 2900