N/A
N=181
The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
Sleep Apnea Syndromes · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT00371293 ↗Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Inflammation — -11.47; -37.45; -32.66 percentage of change in crp at week 24
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight Loss Program (Behavioral); CPAP therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammation |
-11.47; -37.45; -32.66 | — |
| SECONDARY Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml) |
.06; .43; .74 | — |
| SECONDARY Change in LDL Cholesterol Levels |
-3.76; -9.25; -13.54 | — |
| SECONDARY Change in Triglyceride Levels |
-7.1; -23.2; -53 | — |
| SECONDARY Change in HDL Cholesterol Levels |
-0.62; 0.71; 0.49 | — |
Summary
Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. This study will evaluate whether OSA or obesity plays the primary role in inflammation related to heart disease. The study will also determine the independent effects of OSA and obesity on insulin resistance and blood vessel function.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe OSA (as defined by an apnea-hypopnea index [AHI] score greater than 15 events per hour)
- Body mass index greater than 30 kg/m
- Baseline CRP greater than 1.0 mg/dL
Exclusion Criteria
- Predominant central sleep apnea
- Type 1 Diabetes
- Type 2 Diabetes associated with either: (a) unstable anti-diabetic therapy (anti-diabetic medication changes within past 3 months); (b) Hemoglobin A1C levels > 7%; (c) Inability to perform home blood glucose monitoring (fingerstick checks).
- Requires use of supplemental oxygen
- Acute coronary syndrome or stroke in the 3 months prior to study entry
- A high-risk occupation or motor vehicle driving record, as defined by a score of 10 points or higher on an occupational and driving habits questionnaire
- Blood pressure greater than 160/95 mm Hg (may be re-screened after blood pressure control is obtained)
- Active infection, cancer, or chronic inflammatory disorder
- Use of systemic steroids
- Currently on an unstable dose of statin therapy (participants taking statins must be on a stable dose for at least 8 weeks prior to study entry)
- Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
- Consumes more than 14 alcoholic drinks per week
- History of surgery in the 3 months prior to study entry
- Sustained ventricular or supraventricular tachycardia greater than 30 seconds during overnight sleep study
- Known left ventricular ejection fraction less than 30% or decompensated congestive heart failure requiring hospitalization in the year prior to study entry
- Any episode of decompensated respiratory function requiring hospitalization in the year prior to study entry
- Severe restless leg syndrome or chronic pain syndrome that gives rise to frequent awakenings at night, as determined during the overnight sleep study (individuals may still be enrolled if these sleep-disrupting disorders can be resolved prior to study entry)
- Pregnant or likely to become pregnant (i.e., pre-menopausal and not using a form of birth control)
- Severe depression, as defined by a score of 29 or higher on the Beck Depression Index, or suicidal ideation
- Serious medical or psychological condition that may compromise the participant's safety or successful participation in the study, in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT00371293). 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.