Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention

Last updated: March 22, 2023
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04025528
258045
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients 18 years or older
  2. BMI > 40
  3. Patients with significant sleep disordered breathing requiring treatment
  4. Patient is being assessed for bariatric surgery for either gastric sleeve or gastricbypass surgery

Exclusion

Exclusion Criteria:

  1. Patients with decompensated hypercapnic respiratory failure (pH< 7.3)
  2. Chronic hypercapnic respiratory failure due to a cause other than obesity such asneuromuscular, chest wall or airway disease
  3. Unstable cardiac disease including coronary artery disease and heart failure
  4. Significant co-morbid psychiatric disease requiring anti-psychotic medications
  5. Chronic pain syndrome on high dose opioid medications
  6. Treatment for drug or alcohol addiction
  7. Cognitive impairment that would prevent informed consent
  8. Pregnancy
  9. Need for long-term renal replacement therapy
  10. Patients who undergo bariatric intervention with gastric balloon or gastric band.

Study Design

Total Participants: 30
Study Start date:
June 20, 2019
Estimated Completion Date:
July 31, 2024

Connect with a study center

  • Guy's and St Thomas' NHS Trust

    London, SE17EH
    United Kingdom

    Active - Recruiting

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