Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01380418
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2011-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Associated With Chronic Respiratory Failure in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, fat, muscle'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the physiological between obese patients with OHS and obese patients without OHS', 'timeFrame': '1 year', 'description': 'This will be a detailed ventilatory drive measurements and muscle strength testing. The comparison will be made within the group amongst the range of ventilatory failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity', 'Obesity Hypoventilation Syndrome']}, 'referencesModule': {'references': [{'pmid': '27335651', 'type': 'DERIVED', 'citation': 'Dattani RS, Swerner CB, Stradling JR, Manuel AR. Exploratory study into the effect of abdominal mass loading on airways resistance and ventilatory failure. BMJ Open Respir Res. 2016 Jun 9;3(1):e000138. doi: 10.1136/bmjresp-2016-000138. eCollection 2016.'}, {'pmid': '26918192', 'type': 'DERIVED', 'citation': 'Manuel AR, Hart N, Stradling JR. Correlates of obesity-related chronic ventilatory failure. BMJ Open Respir Res. 2016 Feb 18;3(1):e000110. doi: 10.1136/bmjresp-2015-000110. eCollection 2016.'}, {'pmid': '25080050', 'type': 'DERIVED', 'citation': 'Manuel ARG, Hart N, Stradling JR. Is a raised bicarbonate, without hypercapnia, part of the physiologic spectrum of obesity-related hypoventilation? Chest. 2015 Feb;147(2):362-368. doi: 10.1378/chest.14-1279.'}]}, 'descriptionModule': {'briefSummary': 'Some overweight individuals develop problems with their breathing such that they gradually breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the blood, called ventilatory failure. As a consequence, if such a person develops a chest infection, they are more likely to become seriously ill and need intensive care. In addition they are much more likely to develop severe complications during and following operations. This problem can be treated with a machine at home used overnight to help breathing. It is interesting that ventilatory failure only happens in some overweight individuals, and the investigators do not understand what factors make this complication develop. There are a number of theories: for example the distribution of the fat, additional lung disease (such as asthma), the addition of obstructive sleep apnoea, a condition when there are periods of cessation of breathing overnight (which is more common in obese individuals), weak muscles of breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other hormonal changes.\n\nThe investigators intend to measure many potential factors in a range of overweight individuals, some who have ventilatory failure, and some who do not, to try and work out which are the important factors that cause this problem. If the investigators can identify such factors, then this will help predict in advance who is at risk from chest infections and during operations; thus allowing for earlier provision of an overnight breathing machine. This should reduce complications and potentially deaths in such individuals.', 'detailedDescription': 'To test the hypothesis that in obese patients with obesity-hypoventilation (OHS) there are specific factors related to the development of ventilatory failure, compared to obese subjects not in ventilatory failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese (BMI \\> 30kg/m2) with or without OHS (18-85yrs)\n\n1. Admitted for management of OHS\n2. Attending the sleep and ventilation clinic\n3. Being assessed for bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese (BMI \\> 30) with or without obesity hypoventilation\n* (OHS) (18 - 85yrs)\n* Admitted for management of their OHS\n* Attending the sleep and ventilation clinic\n* Being assessed for bariatric surgery\n* Willing and able to give informed consent for participation in the study\n* Men and women aged 18 - 85 years\n\nExclusion Criteria:\n\n* Respiratory acidosis pH \\<7.30\n* Severe untreated hypothyroidism\n* Current treatment with theophylline\n* Current treatment with diuretics\n* Severe restrictive or obstructive lung disease (\\<30% predicted)\n* Severe comorbidities such as moderate/severe COPD, left sided heart failure, and primary CNS or neuromuscular diseases\n* Contraindications to MRI scanning\n* Contraindications to DXA scanning\n* Previous participant in research in the last 12 months'}, 'identificationModule': {'nctId': 'NCT01380418', 'briefTitle': 'Factors Associated With Chronic Respiratory Failure in Obesity', 'nctIdAliases': ['NCT01385462'], 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study', 'orgStudyIdInfo': {'id': '11/H0605/9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Obese BMI\\>30 18-85 years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LJ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe NHS Trust Hospitals', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'John Stradling, FRCP MBBS PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ari Manuel', 'investigatorFullName': 'Ari Manuel', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}