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

Obesity Clinical Trial

— Maigrir_OT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278285
• Other study ID #: 21-AOIP-01
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: ROUX Christian, PhD
• Phone: +3349209220
• Email: roux.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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
• 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.

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital de l'Archet	Nice	Alpes-maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fibrosis rate	compare adipose tissue caracteristics between patients treated by analog GLP1 and not treated by analog GLP1	At surgery