Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell function and the protective effects of Exenatide: a single-center, randomized, double-blind, placebo-controlled crossover study in healthy volunteers - PREDEX-study

Vrije Universiteit Medisch Centrum0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•-written informed consent
•-Caucasian male
•-18 years * age * 35 years (extremes included) on the day of the first visit
•-BMI * 25.0 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). Dietary advices will be given prior to OGTT (reduced fat intake in the week before OGTT).
•-able to keep a normal day and night rhythm during the trial period (i.e. no shift work)

•-history or presence of a medical disorder
•-use of drugs, except for incidental (non-opiod) analgesic agents
•-first degree relative with type 2 diabetes
•-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)
•-recent changes in weight and/or physical activity
•-serious mental impairment or language problems i.e. preventing to understand the study protocol/aim

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