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Factors Associated With Chronic Respiratory Failure in Obesity

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.
 
ClinicalTrials.gov Identifier: NCT01380418
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ari Manuel, Oxford University Hospitals NHS Trust

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
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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)

  1. Admitted for management of OHS
  2. Attending the sleep and ventilation clinic
  3. 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 *

*   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, Older Adult)
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
Current Responsible Party Ari Manuel, Oxford University Hospitals NHS Trust
Original Responsible Party Heather House, Oxford Radcliffe Hospitals NHS Trust
Current Study Sponsor Oxford University Hospitals NHS Trust
Original Study Sponsor Same as current
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