Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide 1 (GLP-1)
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
- Plasma glucose
研究概览
简要总结
The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are secreted from intestinal cells in relation to a meal and increase insulin secretion from the pancreas. The hormones also exert effects outside the pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1 based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes and obesity. Nonetheless, a new drug is in clinical development: a combined GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone. The mechanism behind these impressive effects are unknown and in this study, the investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and combined and thus elucidate the mechanisms of action of this new drug class.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total pancreatectomy
- •Caucasians between 30-75 years of age
- •Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females
排除标准
- •Pancreatectomy within the last 3 months
- •Ongoing chemotherapy or chemotherapy within the last 3 months
- •Treatment with GLP-1 receptor agonists within the last 3 months
- •Renal impairment (estimated by estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2) and/or albuminuria
- •Calcium related disease, hypo-/hyperthyroidism
- •Known significant liver disease, plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × normal value or INR (The international normalised ratio based on prothrombin time) outside the normal range
- •Severe arteriosclerotic heart disease or heart failure (New York Heart Association (NYHA) group III or IV)
- •Pregnancy and/or breastfeeding
- •Use of more than 14 units of alcohol per week or abuse of narcotics
- •Any condition that the investigator feels would interfere with trial participation
结局指标
主要结局
Plasma glucose
时间窗: Up to two months
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
Plasma glucagon
时间窗: Up to two months
Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days
Plasma Insulin/C-peptide
时间窗: Up to two months
Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days
Plasma triglycerides
时间窗: Up to two months
Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days
Plasma CTX
时间窗: Up to two months
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
Plasma PINP
时间窗: Up to two months
Changes in plasma PINP between interventions assessed through frequently blood sampling during the experimental days
次要结局
未报告次要终点
研究者
Asger Lund, MD
Clinical Associate Professor
University Hospital, Gentofte, Copenhagen