NCT04792762已完成不适用
Physiology of GIP(1-30)NH2 in Humans
University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Insulin
研究概览
简要总结
Glucose-dependent insulinotropic polypeptide (GIP) is a gut-derived incretin hormone that affects glucose, lipid and bone metabolism. Secretion of GIP into the blood stream from enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation of glucose stimulated insulin secretion from the pancreas. The objective of this study is to investigate the physiology of GIP(1-30)NH2 in humans with insulin secretion as the primary endpoint. Furthermore the effects on on plasma/serum levels of glucagon, C-peptide, glucose, bone markers (CTX and P1NP) will be measured.
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
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men of Northern European descent
- •BMI: 19-25 kg/m2
- •Stable body weight (±5%) in the last three months
排除标准
- •Treatment with medication or dietary supplements that cannot be paused for 12 hours
- •More than 14 units of alcohol per week or abuse of narcotics
- •Established liver disease and/or plasma alanine aminotransferase (ALT) ≥3 × normal value and/or INR outside the normal range
- •Renal impairment (eGFR <60 ml/min/1.73 m2)
- •Severe arteriosclerotic heart disease or severe heart failure (NYHA group III or IV)
- •Low blood count (haemoglobin <8.3 mol/l)
- •Special diet or planned body weight change before the trial period
- •First-degree relatives with diabetes
- •Participation in other clinical experiments with medication
- •Any disease/condition that the investigators estimate disturbing for the participation in the experiment
结局指标
主要结局
Insulin
时间窗: Up to 3 months
次要结局
- Glucagon(Up to 3 months)
- Glucose(Up to 3 months)
- P1NP(Up to 3 months)
- C-peptide(Up to 3 months)
- CTX(Up to 3 months)
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen
研究点 (2)
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