Clinical trial NCT02824263: Metabolic Impact of Intermittent CPAP
Official title: Metabolic Impact of Intermittent CPAP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
CPAP
metabolism
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Academy of Sleep Medicine
First posted: 2016-07-06
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.

Detailed description: Participants with a history of moderate severe sleep apnea (AHI\>20) will be enrolled if participants meet inclusion/exclusion criteria. Investigators will report to the sleep laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for 3 nights. The order of observation will be randomized. A standard research dinner is provided before each study. IV's are placed so that blood can be sampled at frequent (30 min) intervals throughout the night. In the morning after each study, a glucose tolerance test and endothelial function study (endoPAT) are performed. Serum samples will be analyzed for glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.

Eligibility criteria: Inclusion Criteria:

* History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)\> 10).
* They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.

Exclusion Criteria:

* Uncontrolled hypertension with systolic blood pressure \>170 or diastolic blood pressure \> 110
* Congestive heart failure
* Use of clonidine or nicotinic acid medication
* Diabetes requiring the use of insulin
* Known pregnancy, by urine testing in women of child-bearing age
* History of falling asleep while driving, near miss
* High risk occupation (pilot, commercial driver)
* Hemoglobin \< 10 g/dL on point of care screening

Primary outcomes:
measure: Concentration of Plasma Free Fatty Acids (FFA, mmol/L)
timeFrame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
measure: Concentration of Plasma Glucose (mg/dl)
timeFrame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
measure: Concentration of Plasma Insulin (mcU/ml)
timeFrame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
measure: Concentration of Plasma Triglycerides (mg/dl)
timeFrame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Secondary outcomes:
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.
measure: Reactive Hyperemia Index (RHI)
timeFrame: 2 nights, <1 month apart, 1 measurement each visit
measure: Augmentation Index (AI)
timeFrame: 2 nights, <1 month apart, 1 measurement each visit
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jonathan C Jun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chopra S, Rathore A, Younas H, Pham LV, Gu C, Beselman A, Kim IY, Wolfe RR, Perin J, Polotsky VY, Jun JC. Obstructive Sleep Apnea Dynamically Increases Nocturnal Plasma Free Fatty Acids, Glucose, and Cortisol During Sleep. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3172-3181. doi: 10.1210/jc.2017-00619.