Sex Steroids, Sleep, and Metabolic Dysfunction in Women - Full Text View

Sponsor:	Washington University School of Medicine
Information provided by (Responsible Party):	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00805207

Purpose

Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndrome and sleep disordered breathing. PCOS affects 5-8% of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea is the most common cause for sleep disordered breathing and particularly prevalent in obese women with PCOS (~50%). Both PCOS and OSA augment the increase in plasma TG concentration associated with obesity, and the effects of polycystic ovary syndrome and obstructive sleep apnea on plasma TG concentration appear to be additive. The mechanisms responsible for the adverse effects on plasma TG metabolism are not known. The primary goal of this project, therefore, is to determine the mechanisms responsible for the increase in plasma triglyceride concentration in obese women with polycystic ovary syndrome and obstructive sleep apnea. It is our general hypothesis that alterations in the hormonal milieu that are characteristic of these two conditions are, at least in part, responsible for the increase in plasma TG concentration in obese women with the conditions. Furthermore, we hypothesize that the hormonal aberrations characteristic of the two conditions are particularly harmful to obese, compared with lean, women.

Condition	Intervention
Polycystic Ovary Syndrome Obstructive Sleep Apnea Obesity	Drug: Progesterone Drug: testosterone Drug: glucocorticoid Device: continuous positive airway pressure Drug: Estrogens

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Resource links provided by NLM:

MedlinePlus related topics: Obesity Polycystic Ovary Syndrome Sleep Apnea

Drug Information available for: Progesterone Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

VLDL-TG secretion and plasma clearance rates, total plasma TG and VLDL-TG concentrations [ Time Frame: before and at the end of interventions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

VLDL-apoB-100 kinetics and plasma TG, VLDL-TG, VLDL-apoC-II, VLDL-apoC-III, and VLDL-apoE concentrations [ Time Frame: before and at the end of the interventions ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Progesterone Obese women with polycystic ovary syndrome or postmenopausal women	Drug: Progesterone Micronized progesterone, 100 mg/d vaginally, 14 days followed by 14 days of placebo. Repeat this cycle 3 times.
Active Comparator: PCOS control Lean and obese healthy women	Drug: testosterone Testosterone gel 1250 ug/d, 21 days
Experimental: OSA Obese women and men with obstructive sleep apnea	Device: continuous positive airway pressure Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks
Active Comparator: OSA control Lean and obese healthy women, and obese men	Drug: glucocorticoid Dexamethasone 0.013 mg/kg fat-free mass daily, 21 days
Experimental: estrogen Postmenopausal women	Drug: Estrogens Estrogen treatment (200 ug daily) administered 14 days followed by 14 days without treatment. Repeat this cycle 3 times.
No Intervention: control Postmenopausal women

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805207

Contacts

Contact: Rachel Burrows, BA

314-747-2627

rburrows@dom.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Bettina Mittendorfer, PhD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00805207 History of Changes
Other Study ID Numbers:	07-0692, NIH P50 HD057796
Study First Received:	December 5, 2008
Last Updated:	February 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

PCOS
sleep apnea
obese

VLDL metabolism
isotope tracer
women

Additional relevant MeSH terms:

Apnea
Obesity
Polycystic Ovary Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Ovarian Cysts
Cysts

Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone

ClinicalTrials.gov processed this record on May 23, 2012