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



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 75
Updated:10/21/2017
Start Date:September 2011
End Date:December 2013

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Sleep, Obesity, and Metabolism in Normal and Overweight Subjects: Effects of CPAP on Glucose Metabolism

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.

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).

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)
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Naresh M Punjabi, MD, PhD
Phone: 301-791-1847
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Baltimore, MD
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