Phase 2
Completed N=50
Effects of Treatment of Sleep Apnea on Metabolic Syndrome
Source: ClinicalTrials.gov NCT01385995 ↗Enrolled (actual)
50
Serious AEs
1.0%
Results posted
Jul 2012
Primary outcomePrimary: Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) — 7; 5 subjects — p=0.57
Summary
The investigators performed a randomized, cross-over controlled clinical trial comparing 8 weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A rigorous assessment of metabolic responses to SDB treatment in this group is of great clinical significance because this sample is at high risk for developing diabetes. The paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of both primary care and sleep medicine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) |
7; 5 | 0.57 |
| SECONDARY Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham |
106.4; 105.6; 171.1; 178.2 | 0.38 |
| SECONDARY Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham |
16.4; 17.2; 110.1; 114.3 | 0.14 |
| SECONDARY Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham |
4.4; 4.6 | 0.18 |
| SECONDARY Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham |
12; 12 | 0.20 |
Eligibility Criteria
Inclusion Criteria
- moderate to severe Sleep Disordered Breathing (SDB) defined by an Apnea Hypopnea Index (AHI) > 15
- had evidence of Impaired Glucose Tolerance (IGT) defined by the mean 2-hour Oral Glucose Tolerance Test (OGTT) glucose of > 140 mg/dl calculated from the two 2-hour OGTTs performed within 3 days of each other
Data sourced from ClinicalTrials.gov (NCT01385995). 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.