Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

Not Applicable

Completed

Conditions: Sleep Apnea
Diabetes

Interventions: Device: REMStar Positive Airway Pressure
Behavioral: LifeStyle Counseling

Registration Number: NCT02454153

Lead Sponsor: Johns Hopkins University

Brief Summary: This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.

Detailed Description: Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 184

Inclusion Criteria

Type 2 diabetics
Age > 21 and ≤ 75 years

Exclusion Criteria

Inability to consent or commit to the required visits
Use of insulin or other injections for diabetes
Weight change of 10% in last six months
Use of oral steroids in the last six months
Pulmonary disease (i.e., COPD)
Renal or hepatic insufficiency
Recent MI or stroke (< 3 months)
Sleep-related hypoventilation
Obesity-hypoventilation syndrome
Morbid Obesity
Occupation as a commercial driver or operator of heavy machinery
Active substance use
Untreated thyroid disease
Pregnancy
Any history of seizures or other neurologic disease
Poor sleep hygiene or sleep disorder other than sleep apnea
Central sleep apnea
Variants of obstructive sleep apnea (e.g., REM-related OSA)
Participants not suitable for the study based on the clinical judgment
Use of any investigational drug within the past 30 days
Participating in another study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REMStar Positive Airway Pressure	REMStar Positive Airway Pressure	Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
LifeStyle Counseling	LifeStyle Counseling	Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.

Primary Outcome Measures

Name	Time	Method
Change in Continuous Glucose Monitoring System Standard Deviation	Baseline and 3 months	Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.

Secondary Outcome Measures

Name	Time	Method
Continuous Glucose Monitoring System Standard Deviation	3 months	The standard deviation of the glucose from continuous glucose monitoring at three months.
Change in Continuous Glucose Monitoring System Mean Glucose	Baseline and 3 months	Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.
Mean Difference in Systolic Blood Pressure	Baseline and 3 months	Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.
Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index	Baseline and 3 months	Endothelial function was measured by the EndoPAT device - difference at 3 months - baseline, by group. The outcome reported is the Reactive Hyperemic Index (RHI). The RHI is a measure of endothelial vasodilator function. The RHI is the post-to-pre occlusion peripheral arterial tone signal ratio in the occluded arm relative to the other arm, which is not occluded. Persons with worse endothelial function have a lower RHI score. Consequently, a low RHI indicates more endothelial dysfunction. A value of 1.67 or less is considered abnormal vascular tone. The reported lower and upper limits in adults with type 2 diabetes is 1.1 - 4.9.
Change in the Epworth Sleepiness Scale	Baseline and 3 months	The Epworth Sleepiness Scale measures self-reported sleep propensity or daytime sleepiness. The range of the scale is 0 to 24 (integers only), with increasing values corresponding to increasing sleepiness. A cut-point of ≥ 11 is also sometimes used to differentiate those with pathological sleepiness (≥ 11) versus those without \< 11. The difference between the three month final visit - the baseline visit score is reported by group
Change in Glycosylated Hemoglobin A1c Level	Baseline and 3 months	Change in point-of-care hemoglobin A1c (%) after three months.
Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion	3 months	Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).
Heart Rate Variability	3 months
Change in Post-Pre Meal Blood Glucose Levels	Baseline and 3 months	The difference from baseline to three months in self-reported in blood glucose levels before and after meals (mg/dL) (post-meal - pre-meal). Data is presented for breakfast, lunch, and dinner.