Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery
1 other identifier
observational
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedStudy Start
First participant enrolled
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 13, 2024
February 1, 2024
4.7 years
March 30, 2022
February 11, 2024
Conditions
Outcome Measures
Primary Outcomes (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
2 months
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
6 months
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
12 months
Secondary Outcomes (9)
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
2 months
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
6 months
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
12 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
2 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
6 months
- +4 more secondary outcomes
Interventions
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
Eligibility Criteria
Eligible patients from CHU St Pierre hospital setting
You may qualify if:
- 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)
You may not qualify if:
- Cognitive impairment - language barrier
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU St Pierre
Brussels, 1000, Belgium
Ionela Bold
Brussels, 1000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of pneumology department
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 7, 2022
Study Start
April 22, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 13, 2024
Record last verified: 2024-02