NCT02360878已完成不适用
The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
Filip Krag Knop1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation
研究概览
简要总结
We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.
详细描述
Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation
时间窗: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
时间窗: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation
时间窗: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 26 weeks after implantation
时间窗: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
次要结局
- Change in basal metabolic rate from baseline 52 weeks after implantation(0, 50, 210 minutes)
- Change in gallbladder emptying from baseline 1 week after implantation(0, 20, 40, 60, 90, 120, 150, 180)
- Change in gallbladder emptying from baseline 26 weeks after implantation(0, 20, 40, 60, 90, 120, 150, 180)
- Change in postprandial glucagon secretion 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucagon secretion 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucose from baseline 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial PYY from baseline 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial PYY from baseline 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial ghrelin from baseline 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in gastric emptying from baseline 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in gastric emptying from baseline 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation(0, 30, 60, 90, 120, 180, 240)
- Change in postprandial insulin secretion from baseline 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial insulin secretion from baseline 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial ghrelin from baseline 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation(0, 30, 60, 90, 120, 180, 240)
- Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation(0, 30, 60, 90, 120, 180, 240)
- Change in basal metabolic rate from baseline 1 week after implantation(0, 50, 210 minutes)
- Change in basal metabolic rate from baseline 26 weeks after implantation(0, 50, 210 minutes)
- Change in gastric emptying from baseline 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in gallbladder emptying from baseline 52 weeks after implantation(0, 20, 40, 60, 90, 120, 150, 180)
- Change in postprandial insulin secretion from baseline 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucagon secretion 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucose from baseline 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial PYY from baseline 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in basal metabolic rate from baseline 3 weeks after explantation(0, 50, 210 minutes)
- Change in gastric emptying from baseline 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in gallbladder emptying from baseline 3 weeks after explantation(0, 20, 40, 60, 90, 120, 150, 180)
- Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation(0, 30, 60, 90, 120, 180, 240)
- Change in postprandial glucagon secretion 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucose from baseline 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial ghrelin from baseline 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial insulin secretion from baseline 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial glucose form baseline 3 weeks after explantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial PYY from baseline 26 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
- Change in postprandial ghrelin from baseline 52 weeks after implantation(-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes)
研究者
Filip Krag Knop
MD, Ph.D.
University Hospital, Gentofte, Copenhagen
研究点 (1)
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