Oxytocin and Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Other: Sleeve Gastreextomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity<br>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<br>* 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.<br>|

What is the study measuring?
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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 |