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

Completed

Conditions: Glucometabolic abnormalities induced by glucocorticoids
metabolic effects of prednisolon
10018424

Registration Number: NL-OMON33811

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

-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)

Exclusion Criteria

-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)
-smoking
-recent changes in weight and/or physical activity
-serious mental impairment or language problems i.e. preventing to understand the study protocol/aim

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess whether a single day infusion of the GLP-1 RA exenatide, as compared<br /><br>to placebo, reverses GC-induced impairment of glucose metabolism in healthy<br /><br>males, quantified as:<br /><br><br /><br>* Glucose tolerance (AUCgluc) during a standardized mixed-meal test </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess whether a single day infusion of the GLP-1 RA exenatide, as compared<br /><br>to placebo, reverses GC-induced acute beta-cell dysfunction in healthy males,<br /><br>quantified as:<br /><br><br /><br>Various measures of beta-cell function, such as:<br /><br>* First-phase insulin secretion during a hyperglycemic clamp test<br /><br>* Second-phase insulin secretion during a hyperglycemic clamp test<br /><br>* Arginine-induced insulin secretion during a hyperglycemic clamp test<br /><br>* Model-derived parameters of beta-cell function a during mixed-meal test</p><br>