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临床试验/NCT03412253
NCT03412253暂停不适用

From Diabetes Care to Diabetes Cure; Could Single-anastomosis Gastric Bypass Be a Safe Bridge to Reach This Target in Non-Obese Patients?

Ain Shams University0 个研究点目标入组 17 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
17
主要终点
Cure of type II DM.

研究概览

简要总结

Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm

详细描述

Background: T2DM has been considered as a chronic progressive incurable metabolic disease. Single-anastomosis gastric bypass (SAGB) was shown to be effective in obese patients in terms of weight reduction and T2DM remission, yet its effect on non-obese diabetics is not extensively studied. In this study, we tried to determine the anthropometric and glycemic outcomes of SAGB as a proposed line of treatment for type II diabetes mellitus (T2DM) patients with body mass index (BMI) 25-30 kg/m2.

Methods: From November 2013 to March 2016, a prospective study has been conducted at Ain-Shams University hospitals on 17 consecutive patients undergone SAGB. The demographic and anthropometric data of the patients, as well as their relevant laboratory results, were reported, other data including anti-diabetic medications, co-morbid metabolic diseases were also assessed. All patients were scheduled for laparoscopic SAGB and were advised to come in regular follow up at 1, 3, 6, 12 and 18 months postoperatively. T2DM Remission is considered if glycosylated hemoglobin (HbA1c) <6.5 % and fasting plasma glucose (FPG) < 126 mg/dl for at least 1 year without medication.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • .Type II diabetic patients.
  • Age: 20-60 years.
  • either gender.

排除标准

  • Previous bariatric surgery.
  • Controlled T2DM.
  • Duration of T2DM >10 years.
  • Patients with endocrinal diseases,
  • Pregnancy.
  • Those unfit for general anesthesia.

结局指标

主要结局

Cure of type II DM.

时间窗: 1Year

T2DM Remission is considered if glycosylated hemoglobin (HbA1c) \<6.5 % and fasting plasma glucose (FPG) \< 126 mg/dl for at least 1 year without medication.

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

Tarek Abouzeid Osman Abouzeid

Principal Investigator

Ain Shams University

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