N/A
Completed N=22
Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01136785 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling — -13.7; -2.9 mg/dl — p=0.01
Summary
The overall goal of the proposed protocol is to rigorously test the hypothesis that CPAP treatment has beneficial effects on glycemic control in patients with both type 2 diabetes (T2DM) and obstructive sleep apnea (OSA). If our hypothesis were to be proven, this would imply that CPAP treatment of OSA in patients with T2DM is an essential component of their glycemic control. The proposed work is thus expected to provide additional preventive and therapeutic approaches in the management of millions of patients with T2DM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling |
-13.7; -2.9 | 0.01 sig |
| PRIMARY Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours |
-12.4; 1.5 | 0.011 sig |
| PRIMARY Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling |
-25.8; 28.4 | 0.071 |
| SECONDARY Change in Mean Plasma Cortisol Level From 24-h Sampling |
-0.1 | 0.754 |
| SECONDARY 24-hr Profile of Plasma Growth Hormone |
-0.02 | 0.308 |
| SECONDARY Change in 24-h Mean Level of Plasma Norepinephrine |
-60.9 | 0.036 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects with type 2 diabetes on a stable medication regimen (no change in diabetic medications in the previous 3 months) will be eligible.
Exclusion Criteria
- Subjects on insulin will be excluded.
- Subjects with unstable cardiopulmonary disease, painful neuropathy, significant psychiatric illness, cognitive impairment and pregnancy will be excluded.
- Shift workers
- Subjects having traveled across >2 time zones less than one month prior to the study
- Diagnosis of a sleep disorder other than OSA by screening polysomnography
- Previous treatment with positive airway pressure or supplemental oxygen
- Requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
- Claustrophobia or other conditions of CPAP intolerance,
- Presence of active infection.
Data sourced from ClinicalTrials.gov (NCT01136785). 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. Informational only — not medical advice.