Factors Associated With Chronic Respiratory Failure in Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Oxford University Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01380418
First received: June 16, 2011
Last updated: July 7, 2011
Last verified: June 2011
  Purpose

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
Obesity
Obesity Hypoventilation Syndrome

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
Obese BMI>30 18-85 years old

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380418

Contacts
Contact: ARI MANUEL, MBBS BSC MRCP 01865741841 ari.manuel@orh.nhs.uk

Locations
United Kingdom
Oxford Radcliffe NHS Trust Hospitals
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Study Director: John Stradling, FRCP MBBS PHD University of Oxford
  More Information

No publications provided

Responsible Party: John Stradling, Oxford Radcliffe Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01380418     History of Changes
Obsolete Identifiers: NCT01385462
Other Study ID Numbers: 11/H0605/9
Study First Received: June 16, 2011
Last Updated: July 7, 2011
Health Authority: Nation Patient Safety Agency: UK

Keywords provided by Oxford University Hospitals NHS Trust:
Obesity

Additional relevant MeSH terms:
Obesity
Obesity Hypoventilation Syndrome
Hypoventilation
Respiratory Insufficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on August 01, 2014