跳至主要内容
临床试验/NCT01481675
NCT01481675已完成不适用

Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.

University of Patras1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Diabetes resolution at 12 months after surgery

研究概览

简要总结

To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.

详细描述

Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • BMI>50kg/m2 to undergo BPDLL
  • BMI 40-50kg/m2 to undergo LSG
  • Diabetes mellitus type 2

排除标准

  • Chronic medical illness
  • Psychiatric illness
  • Substance abuse
  • Previous gastrointestinal surgery

结局指标

主要结局

Diabetes resolution at 12 months after surgery

时间窗: 12 months after surgery

次要结局

  • Changes in PYY response to glucose(12 months after surgery)
  • Weight loss at 12 months after surgery(12 months after surgery)
  • Changes of GLP-1 response to glucose(12 months after surgery)
  • Changes in ghrelin levels(12 months after surgery)

研究者

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

Theodore K. Alexandrides

Professor of Medicine, Head of Endocrine Division

University of Patras

研究点 (1)

Loading locations...

相似试验

Diabetes Resolution and Hormone Changes After BPDLL... | 临床试验