Back to resultsPREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide (PREDEX)
Primary Purpose
Glucocorticoid-induced Glucometabolic Abnormalities, Glucocorticoid-induced Beta-cell Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Placebo
Prednisolone
Prednisolone and Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Glucocorticoid-induced Glucometabolic Abnormalities
Eligibility 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
Sites / Locations
- VU University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
NCT ID
NCT00744224
First Posted
August 28, 2008
Last Updated
January 12, 2010
Sponsor
Amsterdam UMC, location VUmc
Collaborators
National Research Council, Institute of Biomedical Engineering
1. Study Identification
Unique Protocol Identification Number
NCT00744224
Brief Title
PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide
Acronym
PREDEX
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
National Research Council, Institute of Biomedical Engineering
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucocorticoid-induced Glucometabolic Abnormalities, Glucocorticoid-induced Beta-cell Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of placebo with saline infusion
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Single dose of 80 mg prednisolone with saline infusion
Intervention Type
Drug
Intervention Name(s)
Prednisolone and Exenatide
Intervention Description
Prednisolone 80 mg single dose Exenatide infusion 20 mg/min
Primary Outcome Measure Information:
Title
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
Time Frame
Single-day treatment
Secondary Outcome Measure Information:
Title
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
Time Frame
Single day treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela Diamant, MD PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
21216851
Citation
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.
Results Reference
derived
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PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide
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