Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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 syndrome of all body weights.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Insulin; Metformin; Pioglitazone

Criteria

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.