PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00744224
• Date of registration: 28/08/2008
• Primary sponsor: VU University Medical Center
• Public title: PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide PREDEX
• Scientific 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
• Date of first enrolment: February 2009
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00744224
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Netherlands

Contacts

• Name: Michaela Diamant, MD PhD
• Affiliation: VU University Medical Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Glucocorticoid-induced Beta-cell Dysfunction

Glucocorticoid-induced Glucometabolic Abnormalities

Intervention(s)

Drug: Placebo

Drug: Prednisolone

Drug: Prednisolone and Exenatide

Primary Outcome(s)

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 [Time Frame: Single-day treatment]

Secondary Outcome(s)

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 [Time Frame: Single day treatment]

Secondary ID(s)

DC2008pred003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Research Council, Institute of Biomedical Engineering