Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome
21 Years
40 Years
Female
Polycystic Ovary Syndrome
Trial Information
Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome
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.
AIM I. Determine whether identifiable differences can be observed in cognitive and
emotional processing between women with insulin resistant PCOS compared to normal controls
using validated fMRI tasks.
AIM II. Determine whether treatment with oral hypoglycemic agent will alter cognitive
processing as measured with validated fMRI cognitive and emotional tasks.
AIM III. Evaluate the differences in opioid tone in women with insulin resistant PCOS
compared to normal controls.
AIM IV. Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in
women with insulin resistant PCOS.
Inclusion Criteria:
- Subjects with insulin resistant PCOS, irregular menstrual cycles and
hyperandrogenism.
- Normal controls with regular menstrual cycles
- Normal hormonal levels, without hirsutism and acne are BMI matched and screened for
insulin resistance prior to inclusion.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PCOS affected women will be evaluated prior to and following 4-month metformin treatment utilizing the following measures: OGTT, neuropsychological testing battery, fMRI and PET scanning results.
Outcome Time Frame:
Once
Safety Issue:
No
Principal Investigator
Yolanda R Smith, MD, MS
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan, Obstetrics and Gynecology
Authority:
United States: Institutional Review Board
Study ID:
2276
NCT ID:
NCT00670800
Start Date:
January 2008
Completion Date:
December 2015
Related Keywords:
- Polycystic Ovary Syndrome
- Polycystic Ovary Syndrome
- Insulin resistance
- Metformin
- Brain function
- Insulin Resistance
- Polycystic Ovary Syndrome
Name | Location |
|---|---|
| University of Michigan, Michigan Clinical Research Unit | Ann Arbor, Michigan 48109 |
