Factors Associated With Chronic Respiratory Failure in Obesity
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| ClinicalTrials.gov Identifier: NCT01380418 |
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Recruitment Status :
Completed
First Posted : June 27, 2011
Last Update Posted : September 12, 2017
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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 |
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| Obesity Obesity Hypoventilation Syndrome |
| 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 |
| Group/Cohort |
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Study group
Obese BMI>30 18-85 years old
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- 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
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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 |
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
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
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
| United Kingdom | |
| Oxford Radcliffe NHS Trust Hospitals | |
| Oxford, United Kingdom, OX3 7LJ | |
| Study Director: | John Stradling, FRCP MBBS PHD | University of Oxford |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ari Manuel, Oxford University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01380418 History of Changes |
| 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:
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Obesity |
Additional relevant MeSH terms:
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Obesity Respiratory Insufficiency Hypoventilation Obesity Hypoventilation Syndrome Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms 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 |