Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT00371293
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2006-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061217', 'term': 'Weight Reduction Programs'}], 'ancestors': [{'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julio.chirinos@uphs.upenn.edu', 'phone': '2158235800', 'title': 'Julio Chirinos', 'organization': 'UPenn'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'CPAP', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.', 'otherNumAtRisk': 58, 'otherNumAffected': 10, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Combination', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.', 'otherNumAtRisk': 62, 'otherNumAffected': 10, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Weight Loss', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.', 'otherNumAtRisk': 61, 'otherNumAffected': 9, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal Congestion', 'notes': 'Nasal or sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nostril Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of Respiratory Allergy Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '"Shakiness" After IVGTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Burning Sensation after IVGTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lump at site of IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising/Tenderness- IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomited during IVGTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash from Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Type II Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Self Committed to Hospital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Tendonitis of Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Swelling in legs and ankles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Knee Replacement Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Wisdom Teeth Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Rotator Cuff Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Knee Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Leg Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pain in ankle/ lower back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Sprained Wrist/ Bruised Knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Right Flank Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Tooth Extraction and Implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Possible Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'New diagnosis of fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Intestinal Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Right Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Ankle Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Abdominal Pain/ Kidney Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP - Adherent', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'OG001', 'title': 'Weight Loss - Adherent', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.'}, {'id': 'OG002', 'title': 'Combination - Adherent', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.47', 'groupId': 'OG000', 'lowerLimit': '-26.09', 'upperLimit': '6.03'}, {'value': '-37.45', 'groupId': 'OG001', 'lowerLimit': '-49.23', 'upperLimit': '-22.94'}, {'value': '-32.66', 'groupId': 'OG002', 'lowerLimit': '-47.14', 'upperLimit': '-14.22'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'unitOfMeasure': 'percentage of change in crp at week 24', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP - Adherent', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'OG001', 'title': 'Weight Loss - Adherent', 'description': 'Participants will receive take part in a weight loss program.\n\nWeight 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.'}, {'id': 'OG002', 'title': 'Combination - Adherent', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}], 'classes': [{'categories': [{'measurements': [{'value': '.06', 'groupId': 'OG000', 'lowerLimit': '-.34', 'upperLimit': '.46'}, {'value': '.43', 'groupId': 'OG001', 'lowerLimit': '-.04', 'upperLimit': '.9'}, {'value': '.74', 'groupId': 'OG002', 'lowerLimit': '.24', 'upperLimit': '1.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'description': "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.", 'unitOfMeasure': 'x10-4/min-1/μU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LDL Cholesterol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP - Adherent', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'OG001', 'title': 'Weight Loss - Adherent', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.'}, {'id': 'OG002', 'title': 'Combination - Adherent', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.76', 'groupId': 'OG000', 'lowerLimit': '-10.08', 'upperLimit': '2.55'}, {'value': '-9.25', 'groupId': 'OG001', 'lowerLimit': '-16.87', 'upperLimit': '-1.6'}, {'value': '-13.54', 'groupId': 'OG002', 'lowerLimit': '-22.03', 'upperLimit': '-5.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Triglyceride Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP - Adherent', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'OG001', 'title': 'Weight Loss - Adherent', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.'}, {'id': 'OG002', 'title': 'Combination - Adherent', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'groupId': 'OG000', 'lowerLimit': '-24.2', 'upperLimit': '10'}, {'value': '-23.2', 'groupId': 'OG001', 'lowerLimit': '-43.8', 'upperLimit': '-2.6'}, {'value': '-53', 'groupId': 'OG002', 'lowerLimit': '-76', 'upperLimit': '-30.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL Cholesterol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP - Adherent', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'OG001', 'title': 'Weight Loss - Adherent', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.'}, {'id': 'OG002', 'title': 'Combination - Adherent', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'groupId': 'OG000', 'lowerLimit': '-2.74', 'upperLimit': '1.5'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '-1.85', 'upperLimit': '3.27'}, {'value': '0.49', 'groupId': 'OG002', 'lowerLimit': '-2.37', 'upperLimit': '3.34'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CPAP', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'FG001', 'title': 'Weight Loss', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.'}, {'id': 'FG002', 'title': 'Combination', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CPAP', 'description': 'Participants will receive CPAP therapy.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'BG001', 'title': 'Weight Loss', 'description': 'Participants will take part in a weight loss program.\n\nWeight 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.'}, {'id': 'BG002', 'title': 'Combination', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.\n\nWeight 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.\n\nCPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '10', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '10', 'groupId': 'BG001'}, {'value': '49', 'spread': '10', 'groupId': 'BG002'}, {'value': '49', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-18', 'studyFirstSubmitDate': '2006-09-01', 'resultsFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2006-09-01', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-18', 'studyFirstPostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammation', 'timeFrame': 'Measured at Baseline and Week 24'}], 'secondaryOutcomes': [{'measure': 'Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)', 'timeFrame': 'Measured at Baseline and Week 24', 'description': "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."}, {'measure': 'Change in LDL Cholesterol Levels', 'timeFrame': 'Measured at Baseline and Week 24'}, {'measure': 'Change in Triglyceride Levels', 'timeFrame': 'Measured at Baseline and Week 24'}, {'measure': 'Change in HDL Cholesterol Levels', 'timeFrame': 'Measured at Baseline and Week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep Apnea', 'C-Reactive Protein', 'Obesity', 'Insulin Resistance', 'Arterial stiffness'], 'conditions': ['Sleep Apnea Syndromes', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '29038203', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24918371', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThe 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).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderate to severe OSA (as defined by an apnea-hypopnea index \\[AHI\\] score greater than 15 events per hour)\n* Body mass index greater than 30 kg/m\n* Baseline CRP greater than 1.0 mg/dL\n\nExclusion Criteria:\n\n* Predominant central sleep apnea\n* Type 1 Diabetes\n* 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).\n* Requires use of supplemental oxygen\n* Acute coronary syndrome or stroke in the 3 months prior to study entry\n* 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\n* Blood pressure greater than 160/95 mm Hg (may be re-screened after blood pressure control is obtained)\n* Active infection, cancer, or chronic inflammatory disorder\n* Use of systemic steroids\n* 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)\n* Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)\n* Consumes more than 14 alcoholic drinks per week\n* History of surgery in the 3 months prior to study entry\n* Sustained ventricular or supraventricular tachycardia greater than 30 seconds during overnight sleep study\n* Known left ventricular ejection fraction less than 30% or decompensated congestive heart failure requiring hospitalization in the year prior to study entry\n* Any episode of decompensated respiratory function requiring hospitalization in the year prior to study entry\n* 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)\n* Pregnant or likely to become pregnant (i.e., pre-menopausal and not using a form of birth control)\n* Severe depression, as defined by a score of 29 or higher on the Beck Depression Index, or suicidal ideation\n* Serious medical or psychological condition that may compromise the participant's safety or successful participation in the study, in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT00371293', 'briefTitle': 'The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Inflammatory Response to Sleep Apnea in Obese Subjects: The Cardiovascular Effects of Obstructive Sleep Apnea (COSA) Study', 'orgStudyIdInfo': {'id': '442'}, 'secondaryIdInfos': [{'id': 'R01HL080076-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01HL080076-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Participants will receive CPAP therapy.', 'interventionNames': ['Device: CPAP therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will take part in a weight loss program.', 'interventionNames': ['Behavioral: Weight Loss Program']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants will receive CPAP therapy and take part in a weight loss program.', 'interventionNames': ['Behavioral: Weight Loss Program', 'Device: CPAP therapy']}], 'interventions': [{'name': 'Weight Loss Program', 'type': 'BEHAVIORAL', 'description': 'Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.', 'armGroupLabels': ['2', '3']}, {'name': 'CPAP therapy', 'type': 'DEVICE', 'description': 'Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19014', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19014', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Julio A. Chirinos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania, Philadelphia Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Julio A. Chirinos', 'investigatorAffiliation': 'University of Pennsylvania'}}}}