Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism

NCT ID: NCT01503164

Last Updated: 2017-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

Brief Summary

Obstructive sleep apnea affects approximately 2-4% of middle-aged adults in the general population and is associated with several medical conditions including hypertension and coronary artery. Research over the last decade has shown that obstructive sleep apnea may also increase the propensity for insulin resistance, glucose intolerance, and type 2 diabetes mellitus. Positive airway pressure (PAP) is the first line therapy for the treatment of obstructive sleep apnea. While PAP therapy has several favorable effects such as improvements in daytime sleepiness and quality of life, it is not clear whether using PAP therapy can alter metabolic risk. The overall objective of this study is to examine whether treatment of obstructive sleep apnea with positive airway pressure therapy improves glucose tolerance and insulin sensitivity. The primary hypothesis of this study is that PAP therapy of obstructive sleep apnea will improve in insulin sensitivity and glucose metabolism.

Detailed Description

Type 2 diabetes mellitus is one of the most prevalent medical conditions, affecting a staggering 246 million people worldwide. Obstructive sleep apnea is a relatively common and often undiagnosed condition in the general population. Cross-sectional studies of clinic and population-based samples suggest that up to 40% of patients with obstructive sleep apnea have type 2 diabetes and up to 75% of patients with type 2 diabetes have obstructive sleep apnea. There is increasing evidence that the pathophysiological features of intermittent hypoxia and sleep fragmentation may be responsible for altering glucose homeostasis and worsening insulin sensitivity. The mechanisms through which obstructive sleep apnea impairs glucose metabolism are largely unknown. While intermittent hypoxemia and sleep fragmentation are likely to play an essential role, the relative contribution of each in the causal pathway remains to be determined. Moreover, whether the adverse effects of intermittent hypoxia and sleep fragmentation are mediated through an increase in sympathetic nervous system activity, alterations in corticotropic function, and/or systemic inflammation is not known. Furthermore, it remains to be determined whether positive pressure therapy for obstructive sleep apnea has salutary effects on glucose metabolism. Many of the available studies examining the effects of PAP on glucose tolerance and insulin sensitivity are plagued by small sample sizes, lack of a control group, and limited data on compliance with positive pressure therapy. The current study will assess, using a community-based sample, whether treatment of obstructive sleep apnea with positive pressure therapy will improve insulin sensitivity, as assessed by the frequently sample intravenous glucose tolerance test (primary outcome measure).

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Sleep-disordered Breathing

Keywords

Obstructive sleep apnea; Sleep Apnea; Sleep-disordered breathing; Insulin sensitivity; Glucose tolerance; Type 2 diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive pressure therapy (PAP)

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Group Type: ACTIVE_COMPARATOR

Positive Pressure Therapy (PAP)

Intervention Type: DEVICE

Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Lifestyle counseling

Group Type: SHAM_COMPARATOR

LifeStyle Counseling

Intervention Type: BEHAVIORAL

Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Interventions

Positive Pressure Therapy (PAP)

Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Intervention Type: DEVICE

LifeStyle Counseling

Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Intervention Type: BEHAVIORAL

Other Intervention Names

CPAP; Dietary and Lifestyle Counseling

Eligibility Criteria

Inclusion Criteria

• Ability to give informed consent
• Obstructive sleep apnea (untreated)
• Ability to comply with study-related assessments

Exclusion Criteria

• Inability to consent or commit to the required visits
• Diabetes mellitus (fasting glucose > 126 mg/dl)
• Use of insulin or oral hypoglycemic agent
• Weight change of 10% in last six months
• Use of oral steroids in the last six months
• Severe pulmonary disease (i.e., COPD)
• Renal or hepatic insufficiency
• Recent Myocardial Infarction (MI) or stroke (< 3 months)
• Occupation as a commercial driver
• Active substance use
• Untreated thyroid disease
• Pregnancy
• Anemia (Hematocrit < 30%)
• Any history of seizures or other neurologic disease
• Poor sleep hygiene or sleep disorder other than sleep apnea
• Excessive subjective sleepiness (Epworth score > 18)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naresh M Punjabi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.

Reference Type: BACKGROUND

PMID: 11991871 (View on PubMed)

Punjabi NM, Ahmed MM, Polotsky VY, Beamer BA, O'Donnell CP. Sleep-disordered breathing, glucose intolerance, and insulin resistance. Respir Physiol Neurobiol. 2003 Jul 16;136(2-3):167-78. doi: 10.1016/s1569-9048(03)00079-x.

Reference Type: BACKGROUND

PMID: 12853008 (View on PubMed)

Tasali E, Mokhlesi B, Van Cauter E. Obstructive sleep apnea and type 2 diabetes: interacting epidemics. Chest. 2008 Feb;133(2):496-506. doi: 10.1378/chest.07-0828.

Reference Type: BACKGROUND

PMID: 18252916 (View on PubMed)

Punjabi NM; Workshop Participants. Do sleep disorders and associated treatments impact glucose metabolism? Drugs. 2009;69 Suppl 2:13-27. doi: 10.2165/11531150-000000000-00000.

Reference Type: BACKGROUND

PMID: 20047348 (View on PubMed)

Aurora RN, Swartz R, Punjabi NM. Misclassification of OSA severity with automated scoring of home sleep recordings. Chest. 2015 Mar;147(3):719-727. doi: 10.1378/chest.14-0929.

Reference Type: DERIVED

PMID: 25411804 (View on PubMed)

Other Identifiers

2R01HL075078

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00036672

Identifier Type: -

Identifier Source: org_study_id