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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00744224

Acronym

PREDEX

Enrollment

Registered

2008-08-29

Start date

2009-02-28

Completion date

2010-01-31

Last updated

2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucocorticoid-induced Beta-cell Dysfunction, Glucocorticoid-induced Glucometabolic Abnormalities

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.

Interventions

DRUGPlacebo

Single dose of placebo with saline infusion

DRUGPrednisolone

Single dose of 80 mg prednisolone with saline infusion

DRUGPrednisolone and Exenatide

Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026