Laihdutusleikkauksen Vaikutus Diabetekseen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Changes in the oxidation of lipoproteins
研究概览
简要总结
This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. Meal test with incretin measurements, and feces and blood samplings are performed before and after surgery
Hypotheses are:
- The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells
- The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes
- The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis
- The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation
- The gastric bypass surgery changes cholesterol and bile acid metabolism
- The gastric bypass surgery changes the fecal microbiota
Primary end points are:
- Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
- Changes in the incretine secretion studied with liquid meal test
- Changes in the oxidation of lipoproteins
- Changes in the immunologic markers in ventricle, duodenum and jejunum
- Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
- Changes in fecal microbiota
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diabetes (applies for control patients)
- •BMI over 30 (applies for control patients)
- •Insulin treatment
- •Oral corticosteroid treatment
- •Chronic inflammatory disease
- •Coeliac disease
- •Malignant disease
结局指标
主要结局
Changes in the oxidation of lipoproteins
时间窗: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the incretine secretion studied with liquid meal test
时间窗: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in fecal microbiota
时间窗: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the immunologic markers in ventricle, duodenum and jejunum
时间窗: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
时间窗: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
时间窗: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
次要结局
未报告次要终点