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Sex Steroids, Sleep, and Metabolic Dysfunction in Women


N/A
18 Years
75 Years
Not Enrolling
Both
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Bettina Mittendorfer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

07-0692

NCT ID:

NCT00805207

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

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110