Glucocorticoid-induced Glucometabolic AbnormalitiesPREDEXNCT00744224
PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide
A study testing Prednisolone and Prednisolone and Exenatide in people with Glucocorticoid-induced Glucometabolic Abnormalities and Glucocorticoid-induced Beta-cell Dysfunction, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucocorticoid-induced Glucometabolic Abnormalities, Glucocorticoid-induced Beta-cell Dysfunction
- What is being tested?
- Prednisolone and Prednisolone and Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081HV
About this study
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
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
- Being tested
- Placebo, Prednisolone, Prednisolone and Exenatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single dose of placebo with saline infusion
PrednisoloneDrug
Single dose of 80 mg prednisolone with saline infusion
Prednisolone and ExenatideDrug
Prednisolone 80 mg single dose Exenatide infusion 20 mg/min
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: Prednisolone |
| 3 | Active comparator | Not described Receives: Drug: Prednisolone and Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Single day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucocorticoid-induced Glucometabolic AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Institute of Biomedical Engineering
- Investigators
- Michaela Diamant, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744224
- Sponsor's protocol ID
- DC2008pred003
- Acronym
- PREDEX
- Status last verified
- Jan 2010
- First submitted
- 28 Aug 2008
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21216851
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00744224
- Acronym / sponsor ID
- PREDEX / DC2008pred003
- Conditions
- Glucocorticoid-induced Glucometabolic Abnormalities, Glucocorticoid-induced Beta-cell Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- National Research Council, Institute of Biomedical Engineering
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: Prednisolone |
| 3 | Active comparator | Drug: Prednisolone and Exenatide |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSingle dose of placebo with saline infusion | Drug | 1 |
| PrednisoloneSingle dose of 80 mg prednisolone with saline infusion | Drug | 2 |
| Prednisolone and ExenatidePrednisolone 80 mg single dose Exenatide infusion 20 mg/min | Drug | 3 |
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
Time frame: Single-day treatment
1 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
Time frame: Single day treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Derived from this study: PubMed 21216851van 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Diamant, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone and Prednisolone and Exenatide in people with Glucocorticoid-induced Glucometabolic Abnormalities and Glucocorticoid-induced Beta-cell Dysfunction, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.