Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Mu-opioid Binding Potential Measured in Left Nucleus Accumbens
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •Use of hormones
- •Centrally acting or insulin sensitizing mediations
- •Allergy to any opioid medication
- •Substance abuse
- •Pregnancy
- •BMI >35.
研究组 & 干预措施
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.
干预措施: Metformin (Drug)
结局指标
主要结局
Mu-opioid Binding Potential Measured in Left Nucleus Accumbens
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Yolanda Smith, M.D.
Professor
University of Michigan