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PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

Information source: VU University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glucocorticoid-induced Glucometabolic Abnormalities; Glucocorticoid-induced Beta-cell Dysfunction

Intervention: Placebo (Drug); Prednisolone (Drug); Prednisolone and Exenatide (Drug)

Phase: N/A

Status: Completed

Sponsored by: VU University Medical Center

Official(s) and/or principal investigator(s):
Michaela Diamant, MD PhD, Principal Investigator, Affiliation: VU University Medical Center

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Male.

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

Locations and Contacts

VU University Medical Center, Amsterdam, Noord-Holland 1081HV, Netherlands
Additional Information

Starting date: February 2009
Last updated: January 12, 2010

Page last updated: August 23, 2015

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