Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.
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
- 否
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
Theodore K. Alexandrides
Professor of Medicine, Head of Endocrine Division
University of Patras
