Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome

University of Michigan

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00670800

2276

HUM00008330 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups

Normal Controls

No Intervention group

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.

PCOS Affected Women-Metformin Treatment

Experimental group

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.

Treatment:

Drug: Metformin