PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

NCT00744224 | Completed

• 1 other identifier: DC2008pred003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

ACTIVE COMPARATOR

Drug: Prednisolone

3

ACTIVE COMPARATOR

Drug: Prednisolone and Exenatide

Interventions

Placebo DRUG

Single dose of placebo with saline infusion

1

Prednisolone DRUG

Single dose of 80 mg prednisolone with saline infusion

2

Prednisolone and Exenatide DRUG

Prednisolone 80 mg single dose Exenatide infusion 20 mg/min

3

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent
• years ≤ age ≤ 35 years on the day of the first visit
• ≤ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• National Research Council, Institute of Biomedical Engineering: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Location

Related Publications (1)

• van Raalte DH, van Genugten RE, Linssen MM, Ouwens DM, Diamant M. Glucagon-like peptide-1 receptor agonist treatment prevents glucocorticoid-induced glucose intolerance and islet-cell dysfunction in humans. Diabetes Care. 2011 Feb;34(2):412-7. doi: 10.2337/dc10-1677. Epub 2011 Jan 7.

  PMID: 21216851 DERIVED

MeSH Terms

Interventions

Prednisolone; Exenatide

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Michaela Diamant, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

NL (1)