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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315752
• Other study ID #: IO-BRUY-CE/220209
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Marie BRUYNEEL, Prof.
• Phone: +3225353686
• Email: marie.bruyneel[@]stpierre-bru.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Investigators are concerned about the high prevalence of Obstructive Sleep Apnoea syndrome (OSA) in the bariatric population. Postoperatively, there is a high rate of recovery from OSA. Indeed, investigators know from previous reports that weight loss is a very effective, but time consuming, strategy for treating OSA. Patients are therefore treated with CPAP (Continuous Positive Airway Pressure) while waiting for weight loss. In a recent meta-analysis, which focused on the effect of weight loss achieved through lifestyle interventions in 618 overweight and obese patients, the apnea-hypopnea index (AHI) decreased by an amount of 16/h for an average weight loss of 14 kg (1). However, the majority of patients are not able to maintain weight loss in the long term, and weight gain is associated with recurrence/aggravation of OSAS (2). Nowadays, bariatric surgery is a common strategy to achieve sustained and significant weight loss in obese patients. Sarkhosh et al. examined the impact of bariatric surgery (restrictive procedures, with a mild malabsorption component, or largely malabsorptive procedures) on sleep apnoea in 13,900 patients. Depending on the procedure, improvement or resolution of OSAS was achieved in 78-90% of patients (3).

Prospective longitudinal postoperative follow-up study : inclusion of patients who had scheduled bariatric surgery, diagnosed with OSA, AHI > 15 (polysomnography), treated with self-controlled CPAP (APAP), under remote monitoring;

Baseline measures:

1. Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + lean mass (bioelectrical impedance measurements),

2. APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP adherence.

Follow-up:

1. The 2-month follow-up: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + fat-free mass (bioelectrical impedance measurements), mean APAP pressure, 95th percentile APAP pressure, APAP adherence. To assess potential regression of OSA with weight loss: home polygraphy after 4 nights off APAP (4).

2. Six-month and 12-month follow-up: same as at 2 months. Follow-up stops in case of a polygraph showing an AHI <10, allowing APAP treatment to be stopped.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Bariatric 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

Country	Name	City	State
Belgium	CHU St Pierre	Brussels
Belgium	Ionela Bold	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	2 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	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	2 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction	Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction	2 months
Secondary	Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction	Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction	6 months
Secondary	Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction	Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction	9 months