Clinical trial · Interventional
Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome
NCT00670800CI-TRIAL-00014622completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the effects of insulin resistance on brain function in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior to and following 4-month treatment with Metformin. Additionally, brain function in women with PCOS will be compared to the brain activity in normal control subjects with regular menstrual cycles.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Normal Controls
- description
- Control subjects will have 5 visits (screening, oral glucose tolerance test (OGTT), neuropsychological testing, functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) as they will receive no treatment and will not have repeat studies. The baseline values obtained from the control subjects will be compared to the baseline values acquired from the PCOS affected subjects.
- type
- EXPERIMENTAL
- label
- PCOS Affected Women-Metformin Treatment
- description
- Subjects with Polycystic Ovary Syndrome (PCOS) will be scheduled for 9 visits total: following the screening visit they will go through OGTT, neuro-psychological testing, fMRI and PET scan before and after 4 months of metformin use: 500mg tablets once daily with breakfast for 1 week, then increased to one tablet twice daily with breakfast \& lunch for 1 week, then increased to one tablet three times daily with breakfast, lunch \& dinner.
- interventionNames
- Drug: Metformin
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Insulin-resistant PCOS (Arm: PCOS Affected Women) * Irregular menstrual cycle (Arm: PCOS Affected Women) * Hyperandrogenism (Arm: PCOS Affected Women) * Regular menstrual cycles (Arm: Normal Controls) * Normal hormonal levels (Arm: Normal Controls) * Lack of hirsutism (Arm: Normal Controls) * Acne-free (Arm: Normal Controls) * Candidates are BMI-matched and screened for insulin resistance prior to inclusion. (Arm: Normal Controls) Exclusion Criteria: * Left handedness * Acute medical illness * Uncorrected thyroid disease * Diabetes renal * Cardiac or pulmonary insufficiency * Active liver disease * Neurological disease * Current psychiatric illness * Claustrophobia * Contraindications to MRI * Smoking * Use of hormones * Centrally acting or insulin sensitizing mediations * Allergy to any opioid medication * Substance abuse * Pregnancy * BMI \>35.
References
Publications (2)
- RESULTBerent-Spillson A, Love T, Pop-Busui R, Sowers M, Persad CC, Pennington KP, Eyvazaddeh AD, Padmanabhan V, Zubieta JK, Smith YR. Insulin resistance influences central opioid activity in polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2494-8. doi: 10.1016/j.fertnstert.2011.03.031. Epub 2011 Apr 12. PMID 21486668
- DERIVEDMarsh CA, Berent-Spillson A, Love T, Persad CC, Pop-Busui R, Zubieta JK, Smith YR. Functional neuroimaging of emotional processing in women with polycystic ovary syndrome: a case-control pilot study. Fertil Steril. 2013 Jul;100(1):200-7.e1. doi: 10.1016/j.fertnstert.2013.02.054. Epub 2013 Apr 1. PMID 23557757