Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery (Maigrir_OT)

March 15, 2024 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Alpes-maritimes
      • Nice, Alpes-maritimes, France, 06200
        • Recruiting
        • CHU de Nice - Hôpital de l'Archet
        • Principal Investigator:
          • Iannelli Antonio, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pregnant or breast-feeding women.
  • Vulnerable patients (under guardianship)
  • Patients deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: whole blood in a GLP1
Oxytocyne assay in a GLP1 analogue or non-analogue patient population
Other: Blood GLP1
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
Other: whole blood in non analague patient population
Oxytocyne assay in a GLP1 analogue or non-analogue patient population
Other: Blood No treated GLP1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of oxytocin
Time Frame: one time (before surgery)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrosis rate
Time Frame: At surgery
compare adipose tissue caracteristics between patients treated by analog GLP1 and not treated by analog GLP1
At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Iannelli Antonio, PhD, CHU de Nice, Service de Chirurgie Digestive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-AOIP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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