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Completed

NCT Number: NCT00670800

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Michigan Clinical Research Unit

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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 names: Glucophage

Primary outcomes

  1. 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.

  2. 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.

  3. 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.)

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2008
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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