PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glucocorticoid-induced Glucometabolic Abnormalities, Glucocorticoid-induced Beta-cell Dysfunction

Intervention / Treatment
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* Drug: Placebo
* Drug: Prednisolone
* Drug: Prednisolone and Exenatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Single dose of placebo with saline infusion<br>|
| Active Comparator: 2<br> | Drug: Prednisolone<br>* Single dose of 80 mg prednisolone with saline infusion<br>|
| Active Comparator: 3<br> | Drug: Prednisolone and Exenatide<br>* Prednisolone 80 mg single dose Exenatide infusion 20 mg/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Single-day treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |