Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

Johns Hopkins University184 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Sleep Apnea Diabetes

Interventions

REMStar Positive Airway PressureDEVICE

Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea

LifeStyle CounselingBEHAVIORAL

Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in Continuous Glucose Monitoring System Standard Deviation

Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.

Time frame: Baseline and 3 months

Secondary Outcomes

Mean Difference in Systolic Blood Pressure

Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.

Time frame: Baseline and 3 months

Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index

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.

Time frame: Baseline and 3 months

Heart Rate Variability

Time frame: 3 months

Change in the Epworth Sleepiness Scale

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

Time frame: Baseline and 3 months

Data from ClinicalTrials.gov

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