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


N/A
21 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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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 UnitAnn Arbor, Michigan  48109