PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

Not Applicable

Completed

• Conditions: Glucocorticoid-induced Glucometabolic Abnormalities; Glucocorticoid-induced Beta-cell Dysfunction
• Interventions: Drug: Prednisolone and Exenatide; Drug: Placebo; Drug: Prednisolone

• Registration Number: NCT00744224
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-28
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2009-02
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	Prednisolone and Exenatide	-
1	Placebo	-
2	Prednisolone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands