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Factors Associated With Chronic Respiratory Failure in Obesity

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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

Study Description
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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.


Condition or disease
Obesity Obesity Hypoventilation Syndrome

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 Design
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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study
Study Start Date : June 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Study group
Obese BMI>30 18-85 years old


Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood, fat, muscle

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380418


Locations
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United Kingdom
Oxford Radcliffe NHS Trust Hospitals
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
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Study Director: John Stradling, FRCP MBBS PHD University of Oxford
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ari Manuel, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01380418    
Obsolete Identifiers: NCT01385462
Other Study ID Numbers: 11/H0605/9
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Keywords provided by Ari Manuel, Oxford University Hospitals NHS Trust:
Obesity
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases