洞察市场格局
解锁药品研发情报

免费客服电话

18983288589

试用企业版

【ChiCTR1900025199】Changes in HOMA-IR Index Levels After Bariatric Surgery: Comparison of Single Anastomosis Duodenal Switch (SADS) and One Anastomosis Gastric Bypass (OAGB-MGB)

查看原文

立即下载

基本信息

登记号

ChiCTR1900025199

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2019-08-16

临床申请受理号

靶点

适应症

肥胖

试验通俗题目

Changes in HOMA-IR Index Levels After Bariatric Surgery: Comparison of Single Anastomosis Duodenal Switch (SADS) and One Anastomosis Gastric Bypass (OAGB-MGB)

试验专业题目

Changes in HOMA-IR Index Levels After Bariatric Surgery: Comparison of Single Anastomosis Duodenal Switch (SADS) and One Anastomosis Gastric Bypass (OAGB-MGB)

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

06830

联系人通讯地址

临床试验信息

试验目的

Bariatric surgery plays a major role in ameliorating metabolic abnormalities of type 2 diabetes (T2DM). The aim of this study was to evaluate the early effects of “Single Anastomosis Duodenal Switch-proximal approach” (SADS-p) and “One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) on the “homeostasis model assessment of insulin resistance” (HOMA-IR) index levels in morbidly obese patients with T2DM.

试验分类

试验类型

连续入组

试验分期

回顾性研究

随机化

N/A

盲法

N/A

试验项目经费来源

own funding

试验范围

目标入组人数

260

实际入组人数

第一例入组时间

2017-05-29

试验终止时间

2018-07-16

是否属于一致性

入选标准

The study was performed according to the principles of the Helsinki Declaration. Ethics Committee of Ankara Liv Hospital approved the study. In this retrospective, parallel group trial, all patients were evaluated for bariatric surgery by a multidisciplinary team of a surgeon, an endocrinologist, a psychologist, dietitian and an anesthesiologist. Two hundred and sixty morbidly obese patients (Body Mass Index>40kg/m2 or Body Mass Index>35kg/m2 + two co-morbidities) who underwent OAGB-MGB (n=200) and SADS-p (n=60) were included in the study. Patients requiring revisional surgery were excluded from the study. Both surgical techniques were described in detail to the patients. Surgical technique was selected considering the presence of T2DM, body mass index (BMI), eating habits, and requests of the patients. Fasting insulin (FI), fasting blood glucose (FBG), HbA1c, “homeostasis model assessment of insulin resistance” (HOMA-IR index), excess weight loss (EWL), and BMI, body weight were collected before surgery and at 1, 3, 9, 12 months after surgery. HOMA-IR index was calculated from FBG and FI levels.；

排除标准

explained above.；

研究者信息

研究负责人姓名

试验机构

土耳其安卡拉伊斯坦尼医科大学

研究负责人电话

研究负责人邮箱

研究负责人邮编

06830

联系人通讯地址

<END>