Oxytocin and Sleeve Gastrectomy

NCT05307133 | Completed

• 1 other identifier: 21-AOI-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• sleeve gastrectomy

  6 months

Study Arms (1)

Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity

OTHER

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

Interventions

Sleeve Gastreextomy 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.

Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06001, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iannelli Antonio, PhD

  CHU de Nice, Service de Chirurgie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: November 24, 2022
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)