Status:
COMPLETED
Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Oregon Health and Science University
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if insulin resistance (how well the body uses insulin and clears sugar) can affect cortisol levels in normal healthy women and women with polycystic ovary syn...
Detailed Description
PCOS is a common clinical problem affecting young women, characterized by oligomenorrhea and hyperandrogenism. Central obesity and insulin resistance are also prominent features of PCOS, and in additi...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Healthy controls):
- Healthy
- At lifetime maximal weight
- Weight stable for at least 6 months prior to study entry
- Willing to commit to not making significant changes to their diet or daily activities while enrolled.
- Premenopausal
- Have regular menstrual cycles
- No evidence of hirsutism
- Additional Inclusion Criteria (Subjects with PCOS):
- Clinical findings of amenorrhea or oligomenorrhea dating from menarche
- Clinical and/or biochemical evidence of hyperandrogenism
- Exclusion of related disorders
- Exclusion Criteria (Healthy controls):
- Less than 18 years of age
- Exercise \> 30 minutes/day, 3 times a week
- Smokers
- Heavy alcohol drinkers (\> 2 drinks/day)
- Type 2 diabetes
- Medical diagnoses including heart disease and cancer
- Psychiatric illness (i.e.depression, psychosis, bipolar, schizophrenia)
- Body weight \> 136 kg
- Pregnant
- Endocrine diseases affecting body composition or androgen levels
- Additional Exclusion Criteria (Subjects with PCOS):
- Laboratory evidence of hyperprolactinemia, thyroid dysfunction, or 21-hydroxylase-deficient nonclassic CAH
- Contraindication to pioglitazone (i.e. CHF, impaired liver function, anemia, depressed leukocyte counts, pulmonary disease, known sensitivity to thiazolidinediones.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00694759
Start Date
October 1 2006
End Date
July 1 2011
Last Update
September 9 2019
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239