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Oxytocin and Sleeve Gastrectomy (BARIA)

Primary Purpose

Obesity, Morbid

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleeve Gastreextomy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity, Morbid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2022
Last Updated
April 4, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05307133
Brief Title
Oxytocin and Sleeve Gastrectomy
Acronym
BARIA
Official Title
Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 5, 2022 (Anticipated)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
April 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Sleeve Gastreextomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
plasma leves of oxytocin
Description
Correlation between plasma leves of oxytocin (pcgr/ml) and weight loss (BMI Kg/m2) 6 months after sleeve gastrectomy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
sleeve gastrectomy
Description
Correlation between weight 6 months after sleeve gastrectomy and fibrosis within adipose tissue
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iannelli Antonio, PhD
Phone
+33492036476
Email
iannelli.a@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Roux Christian, PhD
Phone
+33492039220
Email
roux.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iannelli Antonio, PhD
Organizational Affiliation
CHU de Nice, Service de Chirurgie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06001
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iannelli Antonio, PhD
Phone
+33492036476
Email
iannelli.a@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Iannelli Antonio, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxytocin and Sleeve Gastrectomy

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