PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VU University Medical Center
• Collaborator: National Research Council, Institute of Biomedical Engineering
• Treatments: Exenatide; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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