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OpenTrials
Completed

NCT Number: NCT05307133

Oxytocin and Sleeve Gastrectomy

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes-maritimes, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. plasma leves of oxytocin

    Time frame: 6 months

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

Secondary outcomes

  1. sleeve gastrectomy

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women

Acronym: BARIA

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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