PREDEX: PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Completed

CT.gov ID

NCT00744224

Collaborator

National Research Council, Institute of Biomedical Engineering (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glucocorticoid-induced Glucometabolic Abnormalities Glucocorticoid-induced Beta-cell Dysfunction	Drug: Placebo Drug: Prednisolone Drug: Prednisolone and Exenatide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: Placebo Single dose of placebo with saline infusion
Active Comparator: 2	Drug: Prednisolone Single dose of 80 mg prednisolone with saline infusion
Active Comparator: 3	Drug: Prednisolone and Exenatide Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

Arm

Intervention/Treatment

Placebo Comparator: 1

Drug: Placebo

Single dose of placebo with saline infusion

Active Comparator: 2

Drug: Prednisolone

Single dose of 80 mg prednisolone with saline infusion

Active Comparator: 3

Drug: Prednisolone and Exenatide

Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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