Baltimore, Maryland 21224


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02454153


Primary Contact:

Naresh M Punjabi, MD, PhD
Phone: 410-550-4891
Email: npunjabi@jhmi.edu


Backup Contact:

Email: raurora2@jhmi.edu
Nisha Aurora, MD
Phone: 410-550-4891


Location Contact:

Baltimore, Maryland 21224
United States

Naresh M Punjabi, MD, PhD
Phone: 410-550-4891
Email: npunjabi@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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