N/A
N=14
Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00670800 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Mu-opioid Binding Potential Measured in Left Nucleus Accumbens — 1.95; 1.65; 1.53 ratio — p=0.143
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metformin (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mu-opioid Binding Potential Measured in Left Nucleus Accumbens |
1.95; 1.65; 1.53 | 0.143 |
| PRIMARY Mu-opioid Binding Potential Measured in Right Nucleus Accumbens |
2.40; 2.11; 2.05 | 0.049 sig |
| PRIMARY Mu-opioid Binding Potential Measured in Left Amygdala |
2.28; 2.08; 2.03 | 0.498 |
| PRIMARY Mu-opioid Binding Potential Measured in Right Amygdala |
2.28; 2.11; 2.06 | 0.118 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00670800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.