Factors Associated With Chronic Respiratory Failure in Obesity

Tracking Information
First Submitted Date	June 16, 2011
First Posted Date	June 27, 2011
Last Update Posted Date	September 12, 2017
Study Start Date	June 2011
Actual Primary Completion Date	October 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 24, 2011)	To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ]; 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
Original Primary Outcome Measures; (submitted: June 22, 2011)	To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ]; 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
Change History	Complete list of historical versions of study NCT01380418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Factors Associated With Chronic Respiratory Failure in Obesity
Official Title	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.
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
Study Type	Observational
Study Design	Observational Model: Other; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Blood, fat, muscle
Sampling Method	Non-Probability Sample
Study Population	Obese (BMI > 30kg/m2) with or without OHS (18-85yrs); Admitted for management of OHS; Attending the sleep and ventilation clinic; Being assessed for bariatric surgery
Condition	Obesity; Obesity Hypoventilation Syndrome
Intervention	Not Provided
Study Groups/Cohorts	Study group; Obese BMI>30 18-85 years old
Publications *	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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: September 8, 2017)	78
Original Estimated Enrollment; (submitted: June 22, 2011)	60
Actual Study Completion Date	October 2015
Actual Primary Completion Date	October 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Obese (BMI > 30) with or without obesity hypoventilation; (OHS) (18 - 85yrs); Admitted for management of their OHS; Attending the sleep and ventilation clinic; Being assessed for bariatric surgery; Willing and able to give informed consent for participation in the study; Men and women aged 18 - 85 years Exclusion Criteria: Respiratory acidosis pH <7.30; Severe untreated hypothyroidism; Current treatment with theophylline; Current treatment with diuretics; Severe restrictive or obstructive lung disease (<30% predicted); Severe comorbidities such as moderate/severe COPD, left sided heart failure, and primary CNS or neuromuscular diseases; Contraindications to MRI scanning; Contraindications to DXA scanning; Previous participant in research in the last 12 months
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United Kingdom
Removed Location Countries
Administrative Information
NCT Number	NCT01380418
Other Study ID Numbers	11/H0605/9
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ari Manuel, Oxford University Hospitals NHS Trust
Study Sponsor	Oxford University Hospitals NHS Trust
Collaborators	Not Provided
Investigators	Study Director: John Stradling, FRCP MBBS PHD University of Oxford
PRS Account	Oxford University Hospitals NHS Trust
Verification Date	September 2017