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临床试验/NCT04134156
NCT04134156Unknown不适用

Weight Loss and Change in Ghrelin and GLP-1 Levels After Sleeve Gastrectomy and One-anastomosis Gastric Bypass: a Randomized Clinical Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
excess weight loss

研究概览

简要总结

Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of both genders with morbid obesity (defined as BMI > 40 kg/m2 or > 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included.

排除标准

  • patients ageing more than 60 years
  • patients with endocrine disorders
  • patients with psychiatric disorders that influence perception of the study protocol
  • patients unfit for general anesthesia.

研究组 & 干预措施

Sleeve gastrectomy

Active Comparator

5-port standard sleeve gastrectomy was conducted

干预措施: sleeve gastrectomy (Procedure)

one anastomosis gastric bypass

Active Comparator

5-port standard one-anastomosis gastric bypass was performed

干预措施: one anastomosis gastric bypass (Procedure)

结局指标

主要结局

excess weight loss

时间窗: 12 months after surgery

the percentage of excess weight loss after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Emile

Lecturer of surgery

Mansoura University

研究点 (2)

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