Status:
COMPLETED
Sex Steroids, Sleep, and Metabolic Dysfunction in Women
Lead Sponsor:
Washington University School of Medicine
Conditions:
Polycystic Ovary Syndrome (PCOS)
Obstructive Sleep Apnea
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 facto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00805207
Start Date
September 1 2007
End Date
March 1 2013
Last Update
August 1 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110