NCT00744224已完成不适用
Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers
Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism in healthy males, quantified as glucose tolerance (AUCgluc) during a standardized mixed-meal test
研究概览
简要总结
The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •18 years ≤ age ≤ 35 years on the day of the first visit
- •22.0 ≤ BMI ≤ 28.0 kg/m2
- •(History of) good physical and mental health as determined by history taking, physical and laboratory examinations and ECG.
- •fasting glucose level of < 5.6 mmol/L, in addition to a glucose level of < 7.8 mmol/L at 2 hours after intake of 75 g glucose (OGTT).
- •able to keep a normal day and night rhythm during the trial period (i.e. no shift work)
排除标准
- •history or presence of a medical disorder
- •use of drugs, except for incidental (non-opioid) analgesic agents
- •first degree relative with T2DM
- •performing intensive physical activity > 1x/week
- •an allergic or anaphylactic reaction to prednisolone treatment in the past
- •clinically relevant history or presence of any medical disorder, which are mentioned in the Summary of Product Characteristics (SPC) as contraindication for the use of prednisolone
- •glucocorticosteroid use during the last three months prior to the first dose
- •participation in an investigational drug trial within 90 days prior to the first dose
- •donation of blood (> 100 mL) within 90 days prior to the first dose
- •history of or current abuse of drugs or alcohol (>14 U/week)
- •use of grapefruit products during the study period
- •recent changes in weight and/or physical activity
- •serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Active Comparator
干预措施: Prednisolone (Drug)
3
Active Comparator
干预措施: Prednisolone and Exenatide (Drug)
结局指标
主要结局
To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism in healthy males, quantified as glucose tolerance (AUCgluc) during a standardized mixed-meal test
时间窗: Single-day treatment
次要结局
- To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced acute beta-cell dysfunction in healthy males, quantified as Various measures of beta-cell function(Single day treatment)
研究者
研究点 (1)
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