Oxytocin and Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Other: Sleeve Gastreextomy

• Registration Number: NCT05307133
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-01
• Study Start: 2022-11-24
• Primary Completion: 2024-03-04
• Status Verified: 2025-03
• Study Completion: 2025-03-04
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity	Sleeve Gastreextomy	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).

Primary Outcome Measures

Name	Time	Method
plasma leves of oxytocin	6 months	Correlation between plasma leves of oxytocin (pcgr/ml) and weight loss (BMI Kg/m2) 6 months after sleeve gastrectomy

Secondary Outcome Measures

Name	Time	Method
sleeve gastrectomy	6 months	Correlation between weight 6 months after sleeve gastrectomy and fibrosis within adipose tissue

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes-maritimes, France