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Recruiting NCT06278285

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

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood GLP1, Blood No treated GLP1.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 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.

Primary outcome measures

  • Rate of oxytocin [Time frame: one time (before surgery)]
Secondary outcome measures (1)
  • Fibrosis rate [Time frame: At surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU de Nice - Hôpital de l'Archet — Nice

Identifiers

NCT: NCT06278285 · 21-AOIP-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗