Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- plasma leves of oxytocin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity
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).
干预措施: Sleeve Gastreextomy (Other)
结局指标
主要结局
plasma leves of oxytocin
时间窗: 6 months
Correlation between plasma leves of oxytocin (pcgr/ml) and weight loss (BMI Kg/m2) 6 months after sleeve gastrectomy
次要结局
- sleeve gastrectomy(6 months)