PREDEX

CompletedPhase NA

PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

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

Lead sponsor

Amsterdam UMC, location VUmc

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Healthy volunteers

Key I/E criteria

•BMI ≤28•Male

Primary endpoint

•Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00744224

Org study IDDC2008pred003

Timeline

Milestones

Study first posted2008-08-29estimated

Last update posted2010-01-13estimated

Study start2009-02 (month precision)

Primary completion2010-01actual (month precision)

Study completion2010-01actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age35 Years

SexMale

Healthy volunteersAccepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

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

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint/low confidence

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

descriptive, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glucagon-like peptide-1 receptor agonist treatment prevents glucocorticoid-induced glucose intolerance and islet-cell dysfunction in humans.
Diabetes care2011 Feb (month)PMID21216851doi:10.2337/dc10-1677via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.