Oxytocin and Sleeve Gastrectomy (BARIA)

Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Other: Sleeve Gastreextomy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06001
      • Chu de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma leves of oxytocin	Correlation between plasma leves of oxytocin (pcgr/ml) and weight loss (BMI Kg/m2) 6 months after sleeve gastrectomy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleeve gastrectomy	Correlation between weight 6 months after sleeve gastrectomy and fibrosis within adipose tissue	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Iannelli Antonio, PhD, CHU de Nice, Service de Chirurgie

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Actual): March 4, 2024
• Study Completion (Actual): March 4, 2025

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 21-AOI-12

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