Clinical trial NCT00744224: PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucocorticoid-induced Glucometabolic Abnormalities
Glucocorticoid-induced Beta-cell Dysfunction
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: National Research Council, Institute of Biomedical Engineering
First posted: 2008-08-29
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: 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
timeFrame: Single-day treatment
Secondary outcomes:
measure: 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
timeFrame: Single day treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Michaela Diamant, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Raalte DH, van Genugten RE, Linssen MM, Ouwens DM, Diamant M. Glucagon-like peptide-1 receptor agonist treatment prevents glucocorticoid-induced glucose intolerance and islet-cell dysfunction in humans. Diabetes Care. 2011 Feb;34(2):412-7. doi: 10.2337/dc10-1677. Epub 2011 Jan 7.