TrialGlobe

Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05315752

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Obstructive Sleep Apnea

Full registry criteria

Inclusion Criteria: 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 Criteria: * Cognitive impairment - language barrier

Treatments and study arms

Bariatric surgery

Procedure

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

Primary outcomes

Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI2 months

Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI\<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction

Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI6 months

Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI\<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction

Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI12 months

Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI\<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction

Study locations

2 locations were listed when this page was built. The first 40 are shown.

CHU St Pierre🇧🇪 Brussels, Belgium
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Ionela Bold, MDContact
Email · Call +3225353686
Nathalie Y Pauwen, MScContact
Email · Call +32460955869
Ionela Bold🇧🇪 Brussels, Belgium
Open map
Ionela BoldContact
Email · Call +3225353686
Nathalie Y PauwenContact
Email · Call +32460955869