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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorCentre Hospitalier Universitaire Saint Pierre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Cognitive impairment - language barrier

Trial population

Eligible patients from CHU St Pierre hospital setting

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric surgery

    Procedure/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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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 BMI

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

Time frame
2 months
2

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 BMI

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

Time frame
6 months
3

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 BMI

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

Time frame
12 months

Secondary outcomes

1

Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction

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

Time frame
2 months
2

Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction

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

Time frame
6 months
3

Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction

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

Time frame
12 months
4

Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction

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

Time frame
2 months

Other outcomes

Sponsors and contacts

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