Clinical trial · Interventional
Incretin Effect in PCOS Women
Inkretineffekten Hos Patienter Med Polycystisk Ovariesyndrom før og Efter Behandling af Insulinresistens (Incretin Effect in Patients With Polycystic Ovary Syndrome Before and After Treatment of Insulin Resistance)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin-Placebo
- description
- Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo
- interventionNames
- Drug: Metformin
- Drug: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo-metformin
- description
- 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
- interventionNames
- Drug: Metformin
- Drug: Placebo
Primary outcomes (1)
- measure
- The change in incretin effect from baseline and until after removal of insulin resistance
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 %
References
Publications (0)
Data not yet available