RecruitingNCT05315752

Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery

Changes in Body Fat and Morphologic Characteristics Associated With Obstructive Sleep Apnea (OSA) Resolution After Bariatric Surgery


Sponsor

Centre Hospitalier Universitaire Saint Pierre

Enrollment

60 participants

Start Date

Apr 22, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the resolution of OSA is better than the relationship between these biometric changes and BMI reduction.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • Any informed person who is
  • eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity (BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle adaptations (balanced diet, physical activity) AND
  • with diagnosed obstructive sleep apnoea (OSA) (AHI > 15/hr on polysomnography) AND
  • requiring treatment with Continuous Positive Air Pressure (CPAP)

Exclusion Criteria1

  • Cognitive impairment - language barrier

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Interventions

PROCEDUREBariatric surgery

Bariatric surgery includes (but is not limited to) * Gastric bypass: surgical bypass of the entire stomach, duodenum and approximately 1 m of the proximal small intestine * Sleeve: a large part of the stomach is removed laparoscopically, the open vertical edges are put back in place to leave a sleeve-like tube. Bariatric surgery is considered a treatment option * for patients with a BMI \>40 kg/m 2 , assuming the patient has previously participated successfully in a group weight management programme (weight loss \>7%) or * for patients with a BMI of 35-40 kg/m 2 when the obesity is associated with type 2 diabetes or hypertension, or OAS (with CPAP therapy) or severe musculoskeletal disease


Locations(2)

CHU St Pierre

Brussels, Belgium

Ionela Bold

Brussels, Belgium

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NCT05315752


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