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Sex Steroids, Sleep, and Metabolic Dysfunction in Women

18 Years
75 Years
Not Enrolling
Polycystic Ovary Syndrome, Obstructive Sleep Apnea, Obesity

Thank you

Trial Information

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

VLDL-TG secretion and plasma clearance rates, total plasma TG and VLDL-TG concentrations

Outcome Time Frame:

Before and at the end of interventions

Safety Issue:


Principal Investigator

Bettina Mittendorfer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

March 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Obstructive Sleep Apnea
  • Obesity
  • PCOS
  • sleep apnea
  • obese
  • VLDL metabolism
  • isotope tracer
  • women
  • Apnea
  • Obesity
  • Polycystic Ovary Syndrome
  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive



Washington University School of Medicine Saint Louis, Missouri  63110