Clinical trial NCT00670800: Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
Official title: Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Insulin resistance
Metformin
Brain function
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-05-02
Enrollment: 14
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The pathogenesis of Polycystic Ovary Syndrome (PCOS), a reproductive and metabolic disorder, is associated with insulin resistance. The effects of insulin resistance on cognition, mood, opioid system and reproductive function in PCOS affected women are investigated in the current study. The identification of reversible changes in brain function and reproductive measures in insulin resistant PCOS patients would likely significantly influence treatment protocols for these young women.

1. Evaluate the differences in opioid tone in women with insulin resistant PCOS compared to normal controls.
2. Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in women with insulin resistant PCOS.

Eligibility criteria: 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.

Primary outcomes:
measure: Mu-opioid Binding Potential Measured in Left Nucleus Accumbens
timeFrame: Baseline and after 4 months
measure: Mu-opioid Binding Potential Measured in Right Nucleus Accumbens
timeFrame: Baseline and after 4 months
measure: Mu-opioid Binding Potential Measured in Left Amygdala
timeFrame: Baseline and after 4 months
measure: Mu-opioid Binding Potential Measured in Right Amygdala
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, Michigan Clinical Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan, Obstetrics and Gynecology
name: Yolanda R Smith, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berent-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.
citation: Marsh 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.