Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery
Maigrir_OT
1 other identifier
interventional
40
1 country
1
Brief Summary
Normalizing weight gain and preventing the redistribution of body fat is a major health issue, and could help prevent the onset of various symptoms of metabolic syndrome. Above all, it is important to understand the mechanisms by which these different treatments affect adipose tissue. To this end, the investigators will first study the impact of GLP-1 analogues on adipose tissue. The main objective is to show that subjects treated with a GLP-1 agonist have a significant change in their oxytocin levels compared with subjects not treated with a GLP-1 agonist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Mar 2024
Typical duration for not_applicable obesity
1 active site
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
February 9, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
March 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 6, 2027
March 27, 2026
March 1, 2026
2.5 years
February 9, 2024
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of oxytocin
show that subjects treated with a GLP-1 agonist have a significant change in oxytocin levels compared with subjects not treated with a GLP-1 agonist.
one time (before surgery)
Secondary Outcomes (1)
Fibrosis rate
At surgery
Study Arms (2)
whole blood in a GLP1
OTHEROxytocyne assay in a GLP1 analogue or non-analogue patient population
whole blood in non analague patient population
OTHEROxytocyne assay in a GLP1 analogue or non-analogue patient population
Interventions
On the day of surgery, the surgeon will remove visceral adipose tissue (1 cm3) from the operative waste. The adipose tissue is separated into 2 samples, one frozen in nitrogen, the other embedded in formalin. The samples are then sent to the Institut de Biologie de Valrose (iBV) to assess any differences between the two groups of patients (patients treated with anti-GLP-1 analogues
On the day of surgery, the surgeon will remove visceral adipose tissue (1 cm3) from the operative waste. The adipose tissue is separated into 2 samples, one frozen in nitrogen, the other embedded in formalin. The samples are then sent to the Institut de Biologie de Valrose (iBV) to assess any differences between the two groups of patients (patients treated with patients not treated with anti-GLP-1 analogues) and the presence of fibrosis.
Eligibility Criteria
You may qualify if:
- Patient over 18 years of age.
- Patient able to read and understand the information/consent leaflet.
- Patient with BMI \> 35 with at least one comorbidity. Or BMI \> 40
- Indication for digestive surgery validated in a multidisciplinary consultation meeting and prior agreement accepted by the CPAM.
- Membership of a social security scheme
- Patient's signed informed consent
- For subjects in the GLP-1 analogue group: GLP-1 analogue taken for at least 3 months.
- For non-GLP-1 analogue group: never taken GLP-1 analogues.
You may not qualify if:
- Pregnant or breast-feeding women.
- Vulnerable patients (under guardianship)
- Patients deprived of liberty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes, 06200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iannelli Antonio, PhD
Clinique Parc Impérial, Service de Chirurgie Digestive
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2024
First Posted
February 26, 2024
Study Start
March 6, 2024
Primary Completion (Estimated)
September 6, 2026
Study Completion (Estimated)
March 6, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share