Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- C-peptide levels
研究概览
简要总结
Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.
详细描述
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including lipid, bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the GIPR.
Twelve healthy men (age 18-70 years, BMI 19-27 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal kidney function, liver function and hemoglobin levels.
排除标准
- •Medication, Diabetes type 1 or 2, BMI > 27, first degree relatives with Type 2 Diabetes
研究组 & 干预措施
Placebo
Saline
干预措施: Placebo (Other)
GIP-A
Infusion of GIP-A alone as study tool.
干预措施: GIP-A (Other)
GLP-1 receptor antagonist Exendin[9-39]
Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool.
干预措施: GLP-1 receptor antagonist Exendin[9-39] (Other)
GIP-A + Exendin[9-39]
Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools.
干预措施: GIP-A + Exendin[9-39] (Other)
结局指标
主要结局
C-peptide levels
时间窗: 180 minutes
Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).
次要结局
未报告次要终点
研究者
Lærke Smidt Gasbjerg
MD
University Hospital, Gentofte, Copenhagen