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Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

NCT ID: NCT00696111

Last Updated: 2024-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2022-06-30

Brief Summary

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The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).

Detailed Description

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The prevalence of obesity and chronic sleep loss are at record levels among Americans and evidence continues to emerge to support a causal link between the two conditions. Metabolic abnormalities related to sleep disruption are particularly evident in individuals with obstructive sleep apnea (OSA), a disorder traditionally associated with male gender. While more prevalent in men, OSA is underrecognized in women in part because its clinical and polysomnographic features differ from those of men. Women with polycystic ovary syndrome (PCOS) are particularly susceptible to OSA with at least a 5-fold higher risk for its development compared to obese women without PCOS. This study will enroll obese women with PCOS, with and without OSA. Those with OSA will be randomized to receive CPAP or to receive depot leuprolide to suppress ovarian steroid output over 12 weeks, reassessed at 6 weeks, and then randomized (double-blind, placebo controlled) to 6 weeks of either micronized estrogen + placebo or micronized progestin + placebo. The independent effects of androgen, estrogen, and progesterone on OSA and metabolic function will be assessed. In addition, primary human adipocytes will be prepared from fat biopsies obtained from subjects. Insulin sensitivity will be determined by phospho-specific immunoblotting in conjunction with glucose uptake and anti-lipolysis assays. In parallel, adipocytes from these subjects will be cultured for 1-5 days prior to metabolic assays to ascertain if removal of from circulating factors will improve insulin signaling, or if insulin resistance persists in vitro. Finally, there will be an interface with the Metabolomics Laboratory at Duke University (C. Newgard, Lab Director), and metabolomics assessment will be done on blood and urine samples.

Conditions

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Polycystic Ovary Syndrome Obstructive Sleep Apnea

Keywords

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PCOS OSA Metabolism Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Depot Lupron and estrogen plus placebo

Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.

Group Type EXPERIMENTAL

Depot Lupron followed by estrogen plus placebo

Intervention Type DRUG

A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of estrogen (2mg) plus placebo for six weeks.

Interventions

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Depot Lupron followed by estrogen plus placebo

A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of estrogen (2mg) plus placebo for six weeks.

Intervention Type DRUG

Other Intervention Names

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Arm 1

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of PCOS
* Obese (BMI of at least 30 kg/m2)

Exclusion Criteria

* Diagnosis of nonclassic 21-hydroxylase deficiency, Cushing syndrome, hypothyroidism, or significant elevations in prolactin
* Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
* Positive pregnancy test
* Diagnosis of diabetes mellitus
* Hypertension (systolic \> 140 mmHg and/or diastolic \> 90 mmhg) not well-controlled on stable medication with either ACE inhibitors or diuretics
* Habitual alcohol use
* Excessive caffeine intake of more than 300 mg/day
* Known peanut allergies, or allergies to medications used in the study
* Hemoglobin \< 11g/dL and/or hematocrit \< 33%
* Systemic illnesses, including heart, renal, liver, or malignant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David A Ehrmann, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Hoffman LK, Ehrmann DA. Cardiometabolic features of polycystic ovary syndrome. Nat Clin Pract Endocrinol Metab. 2008 Apr;4(4):215-22. doi: 10.1038/ncpendmet0755. Epub 2008 Feb 5.

Reference Type BACKGROUND
PMID: 18250636 (View on PubMed)

Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A. 2008 Jan 22;105(3):1044-9. doi: 10.1073/pnas.0706446105. Epub 2008 Jan 2.

Reference Type BACKGROUND
PMID: 18172212 (View on PubMed)

Dronavalli S, Ehrmann DA. Pharmacologic therapy of polycystic ovary syndrome. Clin Obstet Gynecol. 2007 Mar;50(1):244-54. doi: 10.1097/GRF.0b013e31802f35a0.

Reference Type BACKGROUND
PMID: 17304039 (View on PubMed)

Ehrmann DA, Liljenquist DR, Kasza K, Azziz R, Legro RS, Ghazzi MN; PCOS/Troglitazone Study Group. Prevalence and predictors of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):48-53. doi: 10.1210/jc.2005-1329. Epub 2005 Oct 25.

Reference Type BACKGROUND
PMID: 16249284 (View on PubMed)

Tasali E, Van Cauter E, Ehrmann DA. Relationships between sleep disordered breathing and glucose metabolism in polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):36-42. doi: 10.1210/jc.2005-1084. Epub 2005 Oct 11.

Reference Type BACKGROUND
PMID: 16219719 (View on PubMed)

Tasali E, Chapotot F, Leproult R, Whitmore H, Ehrmann DA. Treatment of obstructive sleep apnea improves cardiometabolic function in young obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Feb;96(2):365-74. doi: 10.1210/jc.2010-1187. Epub 2010 Dec 1.

Reference Type DERIVED
PMID: 21123449 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.uchicagomedicine.org/conditions-services/endocrinology-metabolic-disorders/polycystic-ovary-syndrome

University of Chicago Center for Polycystic Ovary Syndrome

Other Identifiers

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1P50HD057796

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15872B

Identifier Type: -

Identifier Source: org_study_id