N/A
N=111
Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism
Obstructive Sleep Apnea · Sleep Apnea · Sleep-disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT01503164 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Insulin Sensitivity (SI) — 1.95; 2.22 [mU/L]^-1 x [min]^-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Pressure Therapy (PAP) (Device); LifeStyle Counseling (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity (SI) |
3.01; 1.83 | — |
| PRIMARY Insulin Sensitivity (SI) |
3.01; 1.83 | — |
| SECONDARY Glucose Effectiveness (SG) |
0.01720; 0.01385 | — |
| SECONDARY Glucose Effectiveness (SG) |
0.01720; 0.01385 | — |
| SECONDARY Disposition Index (DI) |
1385.9; 815.4 | — |
| SECONDARY Disposition Index (DI) |
1385.9; 815.4 | — |
| SECONDARY Acute Insulin Response to Glucose (AIRG) |
513.06; 563.64 | — |
| SECONDARY Acute Insulin Response to Glucose (AIRG) |
513.06; 563.64 | — |
| SECONDARY Endothelial Function |
1.90; 1.91 | — |
| SECONDARY Endothelial Function |
1.90; 1.91 | — |
| SECONDARY Area Under the Curve Assessed by Oral Glucose Tolerance Test |
7939.9; 7245.31 | — |
| SECONDARY Area Under the Curve Assessed by Oral Glucose Tolerance Test (OGTT) |
7531.8; 7655.1 | — |
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.
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 ( 18)
Data sourced from ClinicalTrials.gov (NCT01503164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.