Oxytocin and Sleeve Gastrectomy

NCT ID: NCT05307133

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2025-03-04

Brief Summary

Morbid obesity has become a common condition and there is no effective drug that is able to induce a sustained weight loss. Currently bariatric surgery remains the only effective means that is able to lead to long term sustained weight loss. Oxytocin is a hormone secreted by the hypophysis that regulates negatively the adipogenesis and positively the osteogenesis. Oxytocin also regulates appetite and its role in weight loss in humans has not been investigated so far. The aim of the present study is to elucidate whether plasma levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity

After the indication for sleeve gastrectomy has been retained by the multidisciplinary committee eligible patients will be contacted and offered to participate in the BARIAXYTOCINE study. At the time of the first outpatient visit (V1), body densitometry and blood sample for estradiol, leptin and oxytocin will be done. Patients will undergo surgery within one month and 6 months after surgery they will undergo the same work-up (V2).

Group Type: OTHER

Sleeve Gastreextomy

Intervention Type: OTHER

The aim of the present study is to elucidate whether serum levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.

Interventions

Sleeve Gastreextomy

The aim of the present study is to elucidate whether serum levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women aged 18-65, pre-menopausal,
• able to read and understand the written informed consent,
• with a BMI > 40 or 35
• with at least one obesity linked comorbidity among blood hypertension,
• type 2 diabetes,
• sleep apnea syndrome,
• invalidating arthritis,
• indication for sleeve gastrectomy
• accepted by the multidisciplinary committee and the CPAM (local health care system agency),
• affiliation to the Fre,nch health care system,
• signature of the informed consent.

Exclusion Criteria

• Post-menopausal women,
• any other bariatric procedure that sleeve gastrectomy, history of any other bariatric procedure,
• pregnancy,
• age less than 18 years under, under guardianship
• Patients undergoing any other procedure that the planned sleeve gastrectomy or undergoing a second bariatric procedure for a complications during the 6 months follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iannelli Antonio, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice, Service de Chirurgie

Locations

CHU de Nice

Nice, Alpes-maritimes, France

Countries

France

Other Identifiers

21-AOI-12

Identifier Type: -

Identifier Source: org_study_id