Status:
COMPLETED
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Obstructive Sleep Apnea
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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
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 rela...
Eligibility Criteria
Inclusion
- Clinical diagnosis of PCOS
- Obese (BMI of at least 30 kg/m2)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00696111
Start Date
December 1 2007
End Date
June 30 2022
Last Update
December 31 2024
Active Locations (1)
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1
University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism
Chicago, Illinois, United States, 60637