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NCT06597617Recruiting

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

Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
17 Jul 2024
Start date
Jun 2025
Primary completion date
Jun 2028
Lead sponsor
Centre Hospitalier Universitaire de Nice
Diseases
Obesity
NCT number
NCT06597617

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Jun 2025 to the primary completion date, Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient having received antibiotic treatment during the 3 months preceding the first stool collection

Other

  • 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
  • Presence of a contraindication to adapted physical activity
  • Presence of a contraindication to neurostimulation

Who the study is looking for

  • 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)

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Nice
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NiceFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.