The Effects of Neprilysin on Glucagon-like Peptide-1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- GLP-1
研究概览
简要总结
In the current study we wish to investigate the effects on glucagon-like peptide-1 (GLP-1) of a neprilysin inhibitor
详细描述
Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans is unknown. We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and measured plasma concentrations of GLP-1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •body mass index between 20-25
排除标准
- •acute diseases within the two weeks
- •chronic diseases
- •alcoholism, drug addiction or recent weight loss
- •blood donation within the last 3 months
研究组 & 干预措施
Placebo
No treatment. Participants are subjected to a standardized meal
干预措施: Placebos (Drug)
Entrestro as single dose
194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal
干预措施: Entresto (Drug)
Sitagliptin as single dose
200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
干预措施: Sitagliptin 100mg (Drug)
Entrestro + sitagliptin as single dose
194 mg sacubitril / 206 mg valstartan (entresto) + 200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
干预措施: Entresto (Drug)
Entrestro + sitagliptin as single dose
194 mg sacubitril / 206 mg valstartan (entresto) + 200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
干预措施: Sitagliptin 100mg (Drug)
结局指标
主要结局
GLP-1
时间窗: 3 hours after treatment ( during the subsequent standardized meal)
changes in plasma GLP-1 using immunological methods: intact and total GLP-1
次要结局
- C-peptide(3 hours after treatment ( during the subsequent standardized meal))
- Glucagon(3 hours after treatment ( during the subsequent standardized meal))
研究者
Nicolai Jacob Wewer Albrechtsen
Junior Consultant
University of Copenhagen