Factors Associated With Chronic Respiratory Failure in Obesity
| Tracking Information | |||||
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| First Received Date ICMJE | June 16, 2011 | ||||
| Last Updated Date | July 7, 2011 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE |
To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ] [ Designated as safety issue: No ] This will be a detailed sleep study, lung function testing, ventilatory drive measurements and muscle strength testing. The comparison will be made within the group amongst the range of ventilatory failure |
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| Change History | Complete list of historical versions of study NCT01380418 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Factors Associated With Chronic Respiratory Failure in Obesity | ||||
| Official Title ICMJE | Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study | ||||
| Brief Summary | 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. The 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. |
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| Detailed Description | 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood, fat, muscle |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Obese (BMI > 30kg/m2) with or without OHS (18-85yrs)
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Study group
Obese BMI>30 18-85 years old |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01380418 | ||||
| Other Study ID Numbers ICMJE | 11/H0605/9 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | John Stradling, Oxford Radcliffe Hospitals NHS Trust | ||||
| Study Sponsor ICMJE | Oxford University Hospitals NHS Trust | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oxford University Hospitals NHS Trust | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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