Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Insulin levels
研究概览
简要总结
Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.
详细描述
Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.
The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, 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
- 20 Years 至 30 Years（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 > 25, first degree relatives with Type 2 Diabetes
研究组 & 干预措施
Placebo
Infusion of saline
干预措施: Saline (Other)
GIP(1-42)
Infusion of agonist, GIP(1-42)
干预措施: GIP(1-42) (Drug)
GIP-A
Infusion of GIP-A alone
干预措施: GIP-A (Drug)
GIP-A + GIP(1-42)
Infusion of GIP-A and GIP(1-42)
干预措施: GIP-A (Drug)
GIP-A + GIP(1-42)
Infusion of GIP-A and GIP(1-42)
干预措施: GIP(1-42) (Drug)
结局指标
主要结局
Insulin levels
时间窗: 65 minutes
Serum-insulin AUC (area under the curve for hyperglycemic clamp period)
次要结局
未报告次要终点
研究者
Lærke Smidt Gasbjerg
MD
University Hospital, Gentofte, Copenhagen