Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss.
Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation.
Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.
| Condition or disease | Intervention/treatment |
|---|---|
| Obesity Hypoventilation Syndrome (OHS) | Procedure: Bariatric Surgery |
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention: PHOEBI Study |
| Actual Study Start Date : | June 20, 2019 |
| Estimated Primary Completion Date : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Hypercapnic
Obese patients with daytime hypercapnia
|
Procedure: Bariatric Surgery
Weight loss surgery with either gastric sleeve or gastric bypass surgery
|
|
Eucapnic
Obese patients with normal daytime carbon dioxide levels
|
Procedure: Bariatric Surgery
Weight loss surgery with either gastric sleeve or gastric bypass surgery
|
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Michael Cheng, MBBS | +44 02071888070 | michael.cheng@gstt.nhs.uk |
| United Kingdom | |
| Guy's and St Thomas' NHS Trust | Recruiting |
| London, United Kingdom, SE17EH | |
| Contact: Michael Cheng, MBBS +44 02071888070 michael.cheng@gstt.nhs.uk | |
| Principal Investigator: | Joerg Steier, PhD | Guy's and St Thomas NHS Trust |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||
| First Posted Date | July 19, 2019 | ||||
| Last Update Posted Date | July 19, 2019 | ||||
| Actual Study Start Date | June 20, 2019 | ||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title | Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention | ||||
| Official Title | Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention: PHOEBI Study | ||||
| Brief Summary |
Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss. Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation. Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Obese patients who are considering bariatric surgery intervention | ||||
| Condition | Obesity Hypoventilation Syndrome (OHS) | ||||
| Intervention | Procedure: Bariatric Surgery
Weight loss surgery with either gastric sleeve or gastric bypass surgery
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
30 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 2023 | ||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04025528 | ||||
| Other Study ID Numbers | 258045 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Guy's and St Thomas' NHS Foundation Trust | ||||
| Study Sponsor | Guy's and St Thomas' NHS Foundation Trust | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Guy's and St Thomas' NHS Foundation Trust | ||||
| Verification Date | July 2019 | ||||