RYGBP vs RYGBP With Fundus Resection for Morbid Obese Patients With Type 2 Diabetes. Evaluation of the Gastric Fundus in Glycemic Control. A Randomized Clinical Trial.
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
- Change in insulin levels, fasting and postprandial
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:
- Rate of diabetes remission and the role of the gastrointestinal hormones
- Whether fundus resection leads to improved glycemic control
Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile [ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •morbid obesity (ΒΜΙ ≥ 40)
- •type II diabetes mellitus (T2DM)
- •duration of T2DM shorter than 8 years
排除标准
- •pregnancy
- •type 1 diabetes
- •previous gastrointestinal surgeries
- •alcohol consumption
- •depression
- •no compliance
研究组 & 干预措施
RYGBP
Laparoscopic Roux en Y Gastric Bypass
干预措施: Laparoscopic Roux en Y gastric bypass (Procedure)
RYGBP + FR
Laparoscopic Roux en Y Gastric Bypass with fundus resection
干预措施: Laparoscopic Roux en Y gastric bypass with fundus resection (Procedure)
结局指标
主要结局
Change in insulin levels, fasting and postprandial
时间窗: At 6 months and 12 months postoperatively
Insulin levels (μIU/ml)
Diabetes remission in both groups
时间窗: At 6 months and 12 months postoperatively
Change in HbA1c levels
Change in fasting and postprandial glucose levels
时间窗: At 6 months and 12 months postoperatively
Glucose levels (mg/dl)
Change in HOMA - IR
时间窗: At 6 months and 12 months postoperatively
HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)
Change in ghrelin levels
时间窗: At 6 months and 12 months postoperatively
Fasting and postprandial ghrelin levels (pg/ml)
Change in GLP-1 levels
时间窗: At 6 months and 12 months postoperatively
Fasting and postprandial GLP-1 levels (pg/ml)
Change in PYY levels
时间窗: At 6 months and 12 months postoperatively
Fasting and postprandial PYY levels (ng/ml)
Change in glucagon levels
时间窗: At 6 months and 12 months postoperatively
Fasting and postprandial glucagon levels (pg/ml)
次要结局
未报告次要终点
研究者
Dimitrios Kehagias
Principal Investigator
University of Patras