Persistent Organic Pollutants and Mechanical Discharge: Limiting the Impact of Bariatric Surgery Through Personalized Adapted Physical Activity

Not Applicable

Recruiting

• Conditions: Obesity; Bariatric Surgery Candidate
• Interventions: Behavioral: Adapted physical activity with aerobic training [GEA]; Behavioral: Adapted physical activity with strength training [GRM]

• Registration Number: NCT06597617
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

For the most severe cases of obesity, recourse to bariatric surgery is the ultimate solution. Although highly beneficial to individual health, this massive loss of body mass could also have negative effects on metabolism and neuromuscular function. Unfortunately, these effects have been relatively little studied in the scientific literature, and are poorly taken into account in patient follow-up when bariatric surgery has been recommended. One of the adverse effects of bariatric surgery is the release into the bloodstream of Persistent Organic Pollutants (POPs) which, are not only persistent, but also bioaccumulative, toxic and mobile. The major problem is that these circulating POPs are linked to a number of adverse side effects, including reproductive disorders, neurobehavioral alterations, metabolic disorders, gut microbiota alterations inflammatory changes and physiological alterations. POP neurotoxicity could also affect psychomotor abilities and neuromuscular function. In addition, the mechanical unloading (i.e., reduced mechanical stress on muscles) induced by loss of body mass, an effect targeted by bariatric surgery and largely beneficial to the health of individuals, could also alter neuromuscular function and potentially alter muscle architecture and contractile properties. Unfortunately, no data are currently available in the scientific literature to confirm or refute these hypotheses. Physical activity-based intervention strategies may be usefull to counteract the effects of mechanical unloading and the release of POPs as suggested in scientific literature. However it is also possible to question which exercise modality should be preferred. Our hypothesis is that eccentric muscle strengthening would better preserve muscle mass and neuromuscular function while limiting the risks associated with POPs release, compared with an aerobic and a control group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Study Start: 2025-06
• Primary Completion: 2028-06
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patient (18-55 years)
• Patient scheduled for bariatric surgery
• Patient practicing a leisure-time physical activity < 8 hours of moderate intensity per week or < 4 hours of high intensity per week
• Presence of effective contraception (hormonal or mechanical)

Exclusion Criteria

• Patient already involved in another experimental study
• Pregnant (urine pregnancy test) or breast-feeding women
• Patient in a particular situation deemed incompatible with the study by the investigator
• Patients from outside the Alpes-Maritimes and Var departments
• Patient having received antibiotic treatment during the 3 months preceding the first stool collection
• Presence of a contraindication to adapted physical activity
• Presence of a contraindication to neurostimulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEA (Aerobic training)	Adapted physical activity with aerobic training [GEA]	-
GRM (Strength training)	Adapted physical activity with strength training [GRM]	-

Primary Outcome Measures

Name	Time	Method
MVC (Maximum Voluntary Contraction)	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Unit used to quantify MVC (Maximum Voluntary Contraction): Nm. Description: MVC will be obtained using an ergometer and force sensors.
Blood concentration for each POP investigated	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Unit used to quantify blood concentration for each POP (Persistent Organic Pollutant) investigated: ng/g of lipid.

Secondary Outcome Measures

Name	Time	Method
Total POPs blood concentration [∑POPs]	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Total POPs blood concentration \[∑POPs\] (ng/ml) will be obtained with the analysis of a blood sampling by chromatography and spectrometry.
Quantity by POPs category	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Quantity by POPs category (ng/ml) will be obtained with the analysis of a blood sampling by chromatography and spectrometry.
Specific and relative muscle strength	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Specific and relative muscle strength (N m) will be obtained using an ergometer and force sensors.
M-wave	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	M-wave will be obtained using an EMG device.
NAV [Voluntary Activation Level]	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	NAV \[Voluntary Activation Level\] (%) will be obtained using an ergometer, force sensors and a stimulator device
Fatigability	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Fatigability (Δ N m) will be obtained using an ergometer, force sensors and a muscular fatigue protocol.
Pennation angle	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Pennation angle (°) will be obtained by muscle ultrasound imaging.
Muscle thickness	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Muscle thickness (mm) will be obtained by muscle ultrasound imaging.
Fascicle length	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Fascicle length (mm) will be obtained by muscle ultrasound imaging.
Characterization of gut microbiota	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Alpha and beta diversity will be obtained by the analysis of feces collected with specific sampling kit.
Weight	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Weigh (kg) will be obtained by using a weight balance.
Fat mass	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Fat mass (kg and %) will be obtained by using an impedancemeter.
Lean mass	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Lean mass (kg and %) will be obtained by using an impedancemeter.
Body mass index (BMI)	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Body mass index (kg/m\^2) will be obtained by using weight balance and a height chart.
Waist-to-hip ratio	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Waist-to-hip ratio will be obtained by measuring the waist circumference (cm) and the hip circumference (cm) with the WHO protocol.
Total cholesterol	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Total cholesterol (g/l) will be obtained with blood sampling analysis.
Free cholesterol	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Free cholesterol (g/l) will be obtained with blood sampling analysis.
Total intra-serum lipids	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Total intra-serum lipids (g/l) will be obtained with blood sampling analysis.
Phospholipids	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Phospholipids (g/l) will be obtained with blood sampling analysis.
Triglycerides	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.	Triglycerides (g/l) will be obtained with blood sampling analysis.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France