PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide (PREDEX)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Glucocorticoid-induced Glucometabolic Abnormalities; Glucocorticoid-induced Beta-cell Dysfunction

Treatments: Drug: Placebo; Drug: Prednisolone; Drug: Prednisolone and Exenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT00744224

DC2008pred003

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Active Comparator group

Treatment:

Drug: Prednisolone

3

Active Comparator group

Treatment:

Drug: Prednisolone and Exenatide