Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)

NCT00694759 | Completed

• 1 other identifier: OHSUIRB00002532
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 syndrome of all body weights.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome; insulin; PCOS; cortisol regulation; regulation

Outcome Measures

Primary Outcomes (2)

• The comparison of body surface area adjusted cortisol production rate (CPR/BSA) before insulin sensitizing therapy in women with PCOS.

  Before 6 months of insulin sensitizing therapy

• The comparison of body surface area adjusted cortisol production rate (CPR/BSA) after insulin sensitizing therapy in women with PCOS.

  After 6 months of insulin sensitizing therapy

Secondary Outcomes (2)

• Comparisons of 24-hour values for adrenocorticotropic hormone , free-cortisol, and cortisol binding globulin.

  Before 6 months of insulin sensitizing therapy

• Comparisons of 24-hour values for adrenocorticotropic hormone , free-cortisol, and cortisol binding globulin.

  After 6 months of insulin sensitizing therapy

Study Arms (3)

A

ACTIVE COMPARATOR

Pioglitazone will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.

Drug: pioglitazone

B

ACTIVE COMPARATOR

Metformin will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.

Drug: metformin

C

PLACEBO COMPARATOR

Placebo will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.

Drug: placebo

Interventions

pioglitazone DRUG

30 mg for 2 weeks, then 45 mg daily

Also known as: Actos

A

metformin DRUG

500mg twice daily for 1 week, then 1000 mg twice daily

Also known as: Glucophage, Glucophage XR

B

placebo DRUG

capsule twice daily

C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Clinical findings of amenorrhea or oligomenorrhea dating from menarche
• Clinical and/or biochemical evidence of hyperandrogenism

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Bethany J. Klopfenstein, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

US (1)