The Role of Oxytocin in Regulating Blood Glucose
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Insulin secretion - c-peptide
研究概览
简要总结
Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.
详细描述
Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) < 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.
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)
盲法说明
The randomized order of infusions is blinded to both participant and investigator
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •BMI 19-25 kg/m2
排除标准
- •Heart-, liver or kidney disease
- •More than 14 units of alcohol weekly, or drug abuse
- •Smoking or any kind of nicotine products
- •Alanin aminotransferase (ALAT) ≥ 2 × normal range
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1,73m2 or creatinine above normal range
- •Blood pressure > 140/90
- •Hemoglobin < normal range
- •Corrected QT Interval (Qtc) >0,45 sec. at electrocardiogram (ECG) at screening
- •Known disease in the pituitary gland or previous pituitary surgery
- •Any other disease/condition which the trial managers believe may affect participation in the trial
研究组 & 干预措施
Placebo
Infusion of placebo
干预措施: Placebo (Other)
Oxytocin 0.1 IU/min
Infusion of oxytocin 0.1 IU/min
干预措施: Oxytocin (Drug)
Oxytocin 0.2 IU/min
Infusion of oxytocin 0.2 IU/min
干预措施: Oxytocin (Drug)
结局指标
主要结局
Insulin secretion - c-peptide
时间窗: From time 0 to time 180 min
Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide
次要结局
- Glucose(From time 0 minutes to time 180 minutes)
- Insulin(From time 0 minutes to time 180 minutes)
- Glucagon(From time 0 minutes to time 180 minutes)
- GIP(From time 0 minutes to time 180 minutes)
- GLP-1(From time 0 minutes to time 180 minutes)
- Lipids(From time 0 minutes to time 180 minutes)
- Cross-linked C-telopeptide of type I collagen( CTX)(From time 0 minutes to time 180 minutes)
- Procollagen type I N-terminal propeptide (P1NP)(From time 0 minutes to time 180 minutes)
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen