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Factors Associated With Chronic Respiratory Failure in Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380418
First Posted: June 27, 2011
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ari Manuel, Oxford University Hospitals NHS Trust
June 16, 2011
June 27, 2011
September 12, 2017
June 2011
October 2015   (Final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01380418 on ClinicalTrials.gov Archive Site
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Factors Associated With Chronic Respiratory Failure in Obesity
Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study

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.

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
Observational
Observational Model: Other
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Blood, fat, muscle
Non-Probability Sample

Obese (BMI > 30kg/m2) with or without OHS (18-85yrs)

  1. Admitted for management of OHS
  2. Attending the sleep and ventilation clinic
  3. Being assessed for bariatric surgery
  • Obesity
  • Obesity Hypoventilation Syndrome
Not Provided
Study group
Obese BMI>30 18-85 years old

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
October 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01380418
11/H0605/9
No
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Ari Manuel, Oxford University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Not Provided
Study Director: John Stradling, FRCP MBBS PHD University of Oxford
Oxford University Hospitals NHS Trust
September 2017