PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of placebo with saline infusion

2

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Single dose of 80 mg prednisolone with saline infusion

3

Group Type ACTIVE_COMPARATOR

Prednisolone and Exenatide

Intervention Type DRUG

Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

Interventions

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Placebo

Single dose of placebo with saline infusion

Intervention Type DRUG

Prednisolone

Single dose of 80 mg prednisolone with saline infusion

Intervention Type DRUG

Prednisolone and Exenatide

Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes