Glucocorticoids ToxicityPhase 1NCT03023891
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
A Phase 1 study testing Prednisone in people with Glucocorticoids Toxicity and Glucose Intolerance, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucocorticoids Toxicity, Glucose Intolerance
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45 years old (to exclude the effect of age on glucose tolerance);
- BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired insulin response);
- Normal fasting glucose;
- Stable weight for three months before participation
Who cannot join
- BMI >25kg/m2;
- Fasting glucose ≥126 mg/dl
- Shift work or disordered sleep (to exclude individuals with alterations in the hypothalamus-adrenergic axis);
- Any diseases;
- Use of any medication regularly (including over-the-counter);
- Previous exposure to glucocorticoids (within the last year);
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center -CRC
Nashville, Tennessee, 37203
About this study
This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.
Read the detailed description
Prednisone is a potent anti-inflammatory drug that has large variability in its response. The large inter individual variability in the response to prednisone has a genetic component, but the genetic determinants of this variability remain unknown. We propose to use two relevant phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in vivo administration of prednisone, to characterize gene expression patterns and identify variants that are involved in the in vivo response to prednisone.
- Conditions
- Glucocorticoids Toxicity, Glucose Intolerance
- Being tested
- Prednisone
- Keywords
- glucocorticoids, efficacy, metabolic toxicity
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called generic, not applicable
Prednisone 60 mg tablet once
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Each participant will received a single dose of oral 60 mg of prednisone
Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Blood Cell Counts
White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)
Measured: baseline and within 4 and 8 hours after drug administration
Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.
Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)
Measured: baseline and 4-8 hours after drug administration
Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.
Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).
Measured: baseline and 4-8 hours after drug administration
Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.
C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)
Measured: baseline and 4-8 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion10 Jan 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glucocorticoids ToxicityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Vivian Kawai, Vanderbilt University Medical Center
- Investigators
- Vivian K Kawai, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023891
- Sponsor's protocol ID
- 161942
- Other IDs
- 5K23GM117395-03
- Status last verified
- May 2020
- First submitted
- 12 Jan 2017
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
- ClinicalTrials.gov ID
- NCT03023891
- Acronym / sponsor ID
- 161942
- Conditions
- Glucocorticoids Toxicity, Glucose Intolerance
- Keywords
- glucocorticoids, efficacy, metabolic toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.
Detailed description
Prednisone is a potent anti-inflammatory drug that has large variability in its response. The large inter individual variability in the response to prednisone has a genetic component, but the genetic determinants of this variability remain unknown. We propose to use two relevant phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in vivo administration of prednisone, to characterize gene expression patterns and identify variants that are involved in the in vivo response to prednisone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisoneEach participant will received a single dose of oral 60 mg of prednisone Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 45 years old (to exclude the effect of age on glucose tolerance);
- BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired insulin response);
- Normal fasting glucose;
- Stable weight for three months before participation
Key exclusion criteria (7 listed)
- BMI >25kg/m2;
- Fasting glucose ≥126 mg/dl
- Shift work or disordered sleep (to exclude individuals with alterations in the hypothalamus-adrenergic axis);
- Any diseases;
- Use of any medication regularly (including over-the-counter);
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 |
|---|---|---|
| PrednisoneAlso: generic, not applicablePrednisone 60 mg tablet once | Drug | Prednisone |
Primary outcome
White Blood Cell Counts
Time frame: baseline and within 4 and 8 hours after drug administration
White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)
Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
Time frame: baseline and 4-8 hours after drug administration
AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration. Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)
Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
Time frame: baseline and 4-8 hours after drug administration
AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone. Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).
Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
Time frame: baseline and 4-8 hours after drug administration
AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone. C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vivian K Kawai principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prednisone in people with Glucocorticoids Toxicity and Glucose Intolerance, run by Vanderbilt University Medical Center at 1 site in United States.
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 4 inclusion and 7 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 4 Jun 2020. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
White Blood Cell Counts (time frame: baseline and within 4 and 8 hours after drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.