Status:
COMPLETED
PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
National Research Council, Institute of Biomedical Engineering
Conditions:
Glucocorticoid-induced Glucometabolic Abnormalities
Glucocorticoid-induced Beta-cell Dysfunction
Eligibility:
MALE
18-35 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- written informed consent
- 18 years ≤ age ≤ 35 years on the day of the first visit
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00744224
Start Date
February 1 2009
End Date
January 1 2010
Last Update
January 13 2010
Active Locations (1)
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1
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1081HV