Oxytocin and Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

— BARIA  

Official title:

Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05307133
• Other study ID #: 21-AOI-12
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 15, 2025
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nice	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	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	sleeve gastrectomy	Correlation between weight 6 months after sleeve gastrectomy and fibrosis within adipose tissue	6 months