PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

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

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)
• smoking
• 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