Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
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| ClinicalTrials.gov Identifier: NCT00670800 |
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Recruitment Status :
Completed
First Posted : May 2, 2008
Results First Posted : May 15, 2014
Last Update Posted : May 21, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycystic Ovary Syndrome | Drug: Metformin | Not Applicable |
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.
- Evaluate the differences in opioid tone in women with insulin resistant PCOS compared to normal controls.
- Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in women with insulin resistant PCOS.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | August 2009 |
| Actual Study Completion Date : | August 2009 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Normal Controls
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.
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Experimental: PCOS Affected Women-Metformin Treatment
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.
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Drug: Metformin
Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg twice daily (BID), adding a dose after lunch. On the third week, the dose will be increased to 500 mg three times daily (TID), adding a 500 mg tablet after supper. All subjects will be monitored for possible side effects such as nausea, vomiting, diarrhea, anorexia, and abdominal discomfort. These side effects tend to be mild, dose-related and improve with continued use of metformin. Hypoglycemia is rare and tends to occur in the setting of alcohol abuse or prolonged starvation. Malabsorption of vitamin B12 and folate occurs with long-term treatment, although it usually does not lead to anemia.
Other Name: Glucophage |
- Mu-opioid Binding Potential Measured in Left Nucleus Accumbens [ Time Frame: Baseline and after 4 months ]
Mu-opioid binding potential in left nucleus accumbens is measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
Control group was measured at baseline only.
- Mu-opioid Binding Potential Measured in Right Nucleus Accumbens [ Time Frame: Baseline and after 4 months ]
Mu-opioid binding potential in right nucleus accumbens measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
Control group was measured at baseline only.
- Mu-opioid Binding Potential Measured in Left Amygdala [ Time Frame: Baseline and after 4 months ]
Mu-opioid binding potential in left amygdala measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
- Mu-opioid Binding Potential Measured in Right Amygdala [ Time Frame: Baseline and 4 months ]
Mu-opioid binding potential in right amygdala measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
Control group was measured at baseline only.
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| Ages Eligible for Study: | 21 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670800
| United States, Michigan | |
| University of Michigan, Michigan Clinical Research Unit | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | Yolanda R Smith, MD, MS | University of Michigan, Obstetrics and Gynecology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yolanda Smith, M.D., Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00670800 |
| Other Study ID Numbers: |
2276 HUM00008330 ( Other Identifier: The University of Michigan IRBMED ) |
| First Posted: | May 2, 2008 Key Record Dates |
| Results First Posted: | May 15, 2014 |
| Last Update Posted: | May 21, 2014 |
| Last Verified: | May 2014 |
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Polycystic Ovary Syndrome Insulin resistance Metformin Brain function |
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Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Gonadal Disorders Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs |