Status:
SUSPENDED
Obstructive Sleep Apnea and Glucose Metabolism
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Sleep Apnea
Glucose Metabolism Disorders
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
Many adults who are overweight have obstructive sleep apnea (OSA) which disrupts sleep and makes it difficult to breath during the night. OSA increases the risk for a person to become insulin resistan...
Eligibility Criteria
Inclusion
- General Inclusion Criteria (for all subjects):
- Age: ≥30 and ≤70 years,
- BMI: ≥30 and ≤45 kg/m2 or body fat ≥ 30 % for women and ≥ 25 % for men,
- Maximum body circumference \<170 cm
- Weight stable (≤2% change)
- Untrained (≤1 h of structured exercise/wk) for at least 3 months before entering the study
- No diabetes (fasting blood glucose \<126 mg/dl, 2h oral glucose tolerance test (OGTT) glucose \<200 mg/dl, HbA1c ≤6.5%)
- Sleep-related inclusion criteria:
- Subjects without OSA:
- AHI \<5/h of sleep;
- Oxygen desaturation index \<3/h
- No known sleep disorders and periodic limb movement arousal index \<15/h during polysomnography
- Reported sleep duration ≥6 h per night
- Regular sleep schedules (i.e. bedtime between 8 pm and 12 am and wake-time between 4 am and 8 am on all days of the week)
- Subjects with OSA
- AHI ≥10/h of sleep (i.e., moderate to severe OSA)
- Oxygen desaturation index ≥4/h;
- No polysomnogram finding that would trigger immediate PAP treatment as per standard operating protocol in our sleep medicine center (a single SaO2 \<50%, SaO2 \<70% for \>2 minutes, electrocardiogram pause \>5 sec, or ventricular tachycardia \>30 sec), because of the risk of a potentially adverse outcome if they are not randomized to the PAP group
- Periodic limb movement arousal index \<15/h during polysomnography,
- Reported sleep duration ≥6 h per night,
- Regular night-time sleep schedules, defined as bedtime between 8 pm and 12 am and wake-time between 4 am and 8 am on all days of the week.
- General Exclusion Criteria (for all subjects):
- Current treatment for previously diagnosed OSA;
- Self-reported severe difficulty sleeping in unfamiliar environments;
- Metal implants that are incompatible with magnetic resonance imaging;
- Controlled substances, tobacco products, dietary supplements, or medications known or suspected to affect sleep, breathing, upper airway muscle physiology, or glucose metabolism
- Evidence of disease (e.g., diabetes, congestive heart failure; chronic obstructive pulmonary disease; hypoventilation, defined as daytime partial pressure of carbon dioxide (pCO2) \>45 mm Hg; major neurological or neuromuscular disorders; cancer; uncontrolled hypertension; etc.);
- Contraindications to supplemental oxygen or PAP (e.g., recent trans-sphenoidal surgery).
- Unwillingness or inability to provide informed consent
- Study physician considers subject to be unable to safely complete the study protocol
Exclusion
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03408613
Start Date
January 17 2018
End Date
February 1 2028
Last Update
March 25 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110