Vagal Mechanisms Mediating the Effects of Glucagon-Like Peptide 1 (GLP-1) on the Endocrine Pancreas - the Entero-endocrine Axis.
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Insulin secretion
研究概览
简要总结
Investigation of the importance of vagal signaling for the glucohomeostatic effects of GLP-1. The study will include physiological studies of truncally vagotomized participants and matched controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal fasting plasma glucose
- •Normal haemoglobin concentration
- •Cardiaresection with a pyloroplasty
- •Informed consent
排除标准
- •Diabetes mellitus
- •Disposition for diabetes mellitus
- •Intestinal disease (apart from cardia resection+pyloroplasty)
- •Disposition of inflammatory bowel disease
- •Intestinal resection (apart from cardia resection+pyloroplasty)
- •Body mass index (BMI) > 27,5 kg/m2
- •Tobacco use
- •Nephropathy (se-creatinine> 130 µM and/or albuminuria)
- •Liver disease (ALAT and/or ASAT >2 × refference value)
- •known heart condition
- •medicinal use, that may not be paused for 12 hours
- •Obstipation
- •swallowing difficulties
- •previous problems with intestinal tube placement
- •Latex allergy
- •Fructose malabsorption
- •Known diseases in the pharynx
- •Previous facial or cranial fractures
- •Sinusitis
- •Bleeding diathesis
- •Matched controls:
- •Inclusion Criteria:
- •Normal fasting plasma glucose
- •Normal haemoglobin concentration
- •Informed consent
- •Exclusion Criteria:
- •Cardiaresection with a pyloroplasty
- •Diabetes mellitus
- •Disposition for diabetes mellitus
- •Intestinal disease (apart from cardia resection+pyloroplasty)
- •Disposition of inflammatory bowel disease
- •Intestinal resection tarmresektion (apart from cardia resection+pyloroplasty)
- •Body mass index (BMI) > 27,5 kg/m2
- •Tobacco use
- •Nephropathy (se-creatinine> 130 µM and/or albuminuria)
- •Liver disease (ALAT and/or ASAT >2 × refference value)
- •known heart condition
- •medicinal use, that may not be paused for 12 hours
- •Obstipation
- •swallowing difficulties
- •previous problems with intestinal tube placement
- •Latex allergy
- •Fructose malabsorption
- •Known diseases in the pharynx
- •Previous facial or cranial fractures
- •Sinusitis
- •Bleeding diathesis
研究组 & 干预措施
Enteral fructose with DPP-4 inhibition
Enteral fructose + DPP-4 inhibition (sitagliptin)
After DPP4 inhibition using Tablet Sitagliptin 100mg on the evening before and on the morning of experimentation enteral fructose is given via an intestinal tube (intrajejunal) to either truncally vagotomised and control individuals.
干预措施: Tablet Sitagliptin 100mg (evening before and morning of experiments) (Drug)
Enteral fructose with DPP-4 inhibition
Enteral fructose + DPP-4 inhibition (sitagliptin)
After DPP4 inhibition using Tablet Sitagliptin 100mg on the evening before and on the morning of experimentation enteral fructose is given via an intestinal tube (intrajejunal) to either truncally vagotomised and control individuals.
干预措施: Intestinal Fructose administration (Other)
Enteral fructose without DPP-4 inhibition
Enteral fructose without DPP-4 inhibition (sitagliptin) After DPP4 inhibition using Tablet Sitagliptin 100mg on the evening before and on the morning of experimentation enteral fructose is given via an intestinal tube (intrajejunal) to either truncally vagotomised and control individuals.
干预措施: Intestinal Fructose administration (Other)
结局指标
主要结局
Insulin secretion
时间窗: up to 4 hours
Evaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones
次要结局
- Glucagon secretion(4 hours)
- Pancreatic Polypeptide levels(4 hours)
- GIP secretion(4 hours)
- Glucose levels(4 hours)
研究者
Simon Veedfald
MD, PhD
Rigshospitalet, Denmark