From Diabetes Care to Diabetes Cure; Could Single-anastomosis Gastric Bypass Be a Safe Bridge to Reach This Target in Non-Obese Patients?
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
- 否
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
Tarek Abouzeid Osman Abouzeid
Principal Investigator
Ain Shams University
