Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
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) is 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total pancreatectomy
- •Caucasians
- •Blood haemoglobin >7 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-1R agonists within the last 3 months
- •Renal impairment (estimated by eGFR <60 ml/min/1.73 m2) and/or albuminuria
- •Calcium related disease, hypo-/hyperthyroidism
- •Known significant liver disease, ALT or AST >3 times normal value or INR outside normal range
- •Severe arteriosclerotic heart disease or heart failure (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
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
时间窗: Up to two months
mmol/l
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
时间窗: Up to two months
ng/ml
Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days
时间窗: Up to two months
pmol/l
Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days.
时间窗: Up to two months
mmol/l lipoproteins, neutral and complex lipids.
Changes in adiponectin in plasma between interventions, assessed through frequently blood sampling during the experimental days.
时间窗: Up to two months
μg/mL
Changes in plasma lipoproteins between interventions assessed through frequently blood sampling during the experimental days.
时间窗: Up to two months
mg/dl
Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days
时间窗: Up to two months
pmol/l
Changes in plasma P1NP between interventions assessed through frequently blood sampling during the experimental days
时间窗: Up to two months
ng/ml
Changes in brown adipose tissue activity between interventions, assessed by thermographic camera
时间窗: Up to two months
次要结局
未报告次要终点
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen