CompletedNCT00371293Updated Apr 5, 2017Results posted

The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease

An interventional study of Weight Loss Program and CPAP therapy in Sleep Apnea Syndromes and Inflammation, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-05.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 181
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

OSA is a common sleep disorder that is characterized by a brief collapse of the upper airway during sleep. This blockage prevents air from flowing properly into the lungs and causes pauses in breathing. If left untreated, OSA can cause high blood pressure, memory problems, weight gain, impotency, and headaches. It is also associated with an increased risk of inflammation-related heart conditions. Obesity is common among individuals with OSA and it may also be associated with inflammation. It is not known, however, whether the increased risk of heart problems is caused primarily by the inflammatory effects of OSA or obesity.

The most common treatment for OSA is continuous positive airway pressure (CPAP) therapy, in which a mask is worn over the nose during sleep. Air flows through the mask to maintain a level of pressure that keeps the throat open. The most common treatment for obesity is weight loss. This study will determine the primary cause of heart-related inflammation by evaluating the individual and combined effects of CPAP therapy and a weight loss program in treating obese individuals with OSA. The study will also determine the independent effects of these therapies on insulin resistance and blood vessel function (arterial stiffness, central arterial pressures).

This study will enroll obese individuals with moderate to severe OSA for a total of 24 weeks. Potential participants will first take part in an overnight sleep study at the University of Pennsylvania sleep lab. Sensors will monitor body functions during the night, including brain and muscle activity, eye movement, heart rate, breathing effort, air flow, and blood oxygen levels. Eligible participants will then be randomly assigned to CPAP therapy, a weight loss program, or a combination of the two. Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. Participants receiving CPAP therapy will use a CPAP machine each night while they sleep. Study visits for all participants will occur at baseline and Weeks 6, 12, and 24. Blood will be collected to measure levels of triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and levels of C-reactive protein (CRP), which is an inflammation biomarker. Insulin resistance will be evaluated using a glucose tolerance test, and blood vessel function will be evaluated using a brachial artery reactivity test in which artery size and blood flow will be measured with an ultrasound.

Conditions studied

Sleep Apnea Syndromes
Inflammation

Browse trials for

Keywords

Sleep Apnea
C-Reactive Protein
Obesity
Insulin Resistance
Arterial stiffness

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 181 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 181 participants (actual)

Study arms

Active comparator
1
Participants will receive CPAP therapy.
Device: CPAP therapy
Active comparator
2
Participants will take part in a weight loss program.
Behavioral: Weight Loss Program
Experimental
3
Participants will receive CPAP therapy and take part in a weight loss program.
Behavioral: Weight Loss Program · Device: CPAP therapy

Interventions

BehavioralWeight Loss Program
Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
DeviceCPAP therapy
Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.

What researchers measure

Primary outcomes

Inflammation
Time frame: Measured at Baseline and Week 24

Secondary outcomes

Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)
Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman's minimal model.
Time frame: Measured at Baseline and Week 24
Change in LDL Cholesterol Levels
Time frame: Measured at Baseline and Week 24
Change in Triglyceride Levels
Time frame: Measured at Baseline and Week 24
Change in HDL Cholesterol Levels
Time frame: Measured at Baseline and Week 24

Results

Posted Apr 5, 2017

Participant flow

Participant flow — Overall Study
Milestone	CPAP	Weight Loss	Combination
Started	58	61	62
Completed	48	42	46
Not completed	10	19	16

Outcome measures

PrimaryInflammation

Time frame:: Measured at Baseline and Week 24
Reported as:: Mean · percentage of change in crp at week 24

Inflammation
percentage of change in crp at week 24	CPAP - Adherent	Weight Loss - Adherent	Combination - Adherent
Inflammation	-11.47 (-26.09 to 6.03)	-37.45 (-49.23 to -22.94)	-32.66 (-47.14 to -14.22)

SecondaryChange in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)

Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman's minimal model.

Time frame:: Measured at Baseline and Week 24
Reported as:: Mean · x10-4/min-1/μU/ml

Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)
x10-4/min-1/μU/ml	CPAP - Adherent	Weight Loss - Adherent	Combination - Adherent
Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)	.06 (-.34 to .46)	.43 (-.04 to .9)	.74 (.24 to 1.23)

SecondaryChange in LDL Cholesterol Levels

Time frame:: Measured at Baseline and Week 24
Reported as:: Mean · mg/dL

Change in LDL Cholesterol Levels
mg/dL	CPAP - Adherent	Weight Loss - Adherent	Combination - Adherent
Change in LDL Cholesterol Levels	-3.76 (-10.08 to 2.55)	-9.25 (-16.87 to -1.6)	-13.54 (-22.03 to -5.05)

SecondaryChange in Triglyceride Levels

Time frame:: Measured at Baseline and Week 24
Reported as:: Mean · mg/dL

Change in Triglyceride Levels
mg/dL	CPAP - Adherent	Weight Loss - Adherent	Combination - Adherent
Change in Triglyceride Levels	-7.1 (-24.2 to 10)	-23.2 (-43.8 to -2.6)	-53 (-76 to -30.2)

SecondaryChange in HDL Cholesterol Levels

Time frame:: Measured at Baseline and Week 24
Reported as:: Mean · mg/dL

Change in HDL Cholesterol Levels
mg/dL	CPAP - Adherent	Weight Loss - Adherent	Combination - Adherent
Change in HDL Cholesterol Levels	-0.62 (-2.74 to 1.5)	0.71 (-1.85 to 3.27)	0.49 (-2.37 to 3.34)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CPAP	—	0/58 (0%)	10/58 (17.2%)
Combination	—	0/62 (0%)	10/62 (16.1%)
Weight Loss	—	0/61 (0%)	9/61 (14.8%)

Most frequent other events

Showing 10 of 43

Most frequent other events
Event	CPAP	Combination	Weight Loss
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders	6/58	4/62	8/61
Nostril IrritationRespiratory, thoracic and mediastinal disorders	1/58	4/62	0/61
Eye IrritationEye disorders	0/58	3/62	0/61
Nasal CongestionRespiratory, thoracic and mediastinal disorders	2/58	1/62	0/61
"Shakiness" After IVGTTNervous system disorders	0/58	2/62	0/61
Chest PainCardiac disorders	1/58	2/62	1/61
Type II DiabetesEndocrine disorders	0/58	2/62	0/61
Motor Vehicle AccidentInjury, poisoning and procedural complications	0/58	2/62	0/61
FluRespiratory, thoracic and mediastinal disorders	1/58	0/62	1/61
Burning Sensation after IVGTTSkin and subcutaneous tissue disorders	1/58	0/62	0/61

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CPAP	Weight Loss	Combination	Total
Mean	49.8 ± 10	48.3 ± 10	49 ± 10	49 ± 10

Sex: Female, Male
Sex: Female, Male(Participants)	CPAP	Weight Loss	Combination	Total
Female	23	25	29	77
Male	35	36	33	104

Region of Enrollment
Region of Enrollment(participants)	CPAP	Weight Loss	Combination	Total
United States	58	61	62	181

Study locations

2 sites

Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania 19014, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19014, United States

References and documents

Publications

Jain S, Gurubhagavatula I, Townsend R, Kuna ST, Teff K, Wadden TA, Chittams J, Hanlon AL, Maislin G, Saif H, Broderick P, Ahmad Z, Pack AI, Chirinos JA. Effect of CPAP, Weight Loss, or CPAP Plus Weight Loss on Central Hemodynamics and Arterial Stiffness. Hypertension. 2017 Dec;70(6):1283-1290. doi: 10.1161/HYPERTENSIONAHA.117.09392. Epub 2017 Oct 16. PubMed 29038203 ↗
Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187. PubMed 24918371 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00371293
Lead sponsor: University of Pennsylvania
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Responsible party: Julio A. Chirinos (MD, PhD, University of Pennsylvania) — Principal investigator
First posted: Sep 4, 2006
Start date: Sep 2006
Primary completion: Sep 2012
Completion: Dec 2013
Results posted: Apr 5, 2017
Last update: Apr 5, 2017

Study contacts

Julio A. Chirinos, MD

principal investigator · University of Pennsylvania, Philadelphia Veterans Affairs Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Apnea→

Other studies from this sponsor

University of Pennsylvania

Start the discussion