Insulin ResistanceNCT00971724
Biomarkers of Prednisolone Treatment (P05888)
A study testing Prednisolone in people with Insulin Resistance and Hyperglycemia, run by Merck Sharp & Dohme LLC.
Trial summary
Primary objective: To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment. Secondary objectives: To describe the PK of prednisolone and PD of a series of biomarkers. To identify biomarkers that reflect side effects of prednisolone. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Hyperglycemia, Glucose Intolerance
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Mar 2008
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 22 < BMI < 30
- fasting glucose < 5.6 mmol/L and glucose < 7.8 mmol/L 2hr after OGTT
- able and willing to sign informed consent
- history of good physical and mental health
- subject smokes less than 5 cigarettes per day
- able to keep a normal day and night rhythm
Who cannot join
- allergy to prednisolone
- glucocorticoid use during last 3 months prior to study
- use of any drug or substance
- history of familiar diabetes type 2
- clinically relevant history or presence of any medical disorder
- clinically relevant abnormal lab or ECG
- positive drug or alcohol screen, positive hepatitis B or C surface antigen
- donation of blood (>100 mL) within 90 days prior to the first dose
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Single-center Study Using Multiple Doses of Prednisolone to Quantify Effects on Selected Biomarkers and Assess Pharmacokinetics in Healthy Males
Primary objective:
- To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.
Secondary objectives:
- To describe the PK of prednisolone and PD of a series of biomarkers.
- To identify biomarkers that reflect side effects of prednisolone.
- To elucidate part of the mechanisms by which prednisolone induces metabolic changes.
- Conditions
- Insulin Resistance, Hyperglycemia, Glucose Intolerance
- Being tested
- Placebo, Prednisolone
- Keywords
- Prednisolone, Glucocorticoids
- Medical subject headings
- Insulin Resistance, Hyperglycemia, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral administration, once daily, for 15 days
PrednisoloneDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Treatment with placebo for 15 days Receives: Drug: Placebo |
| Prednisolone 7.5 mg daily | Experimental | Treatment with prednisolone 7.5 mg daily for 15 days Receives: Drug: Prednisolone |
| Prednisolone 15 mg daily | Experimental | Treatment with prednisolone 15 mg daily for 15 days Receives: Drug: Prednisolone |
| Prednisolone 30 mg daily | Experimental | Treatment with prednisolone 30 mg daily for 15 days Receives: Drug: Prednisolone |
| Prednisolone 75 mg | Experimental | Treatment with prednisolone 75 mg for a single day Receives: Drug: Prednisolone |
| Prednisolone 15 mg twice daily | Experimental | Treatment with prednisolone 15 mg twice daily for a single day Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
Measured: Day 1 and day 15
Secondary outcomes (1)
To describe the PK of prednisolone and PD of a series of biomarkers
Measured: Day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMay 2006
- Primary completionOct 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971724
- Sponsor's protocol ID
- P05888
- Other IDs
- 294001
- Status last verified
- May 2015
- First submitted
- 3 Sep 2009
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellero-Simatos S, Szymanska E, Rullmann T, Dokter WH, Ramaker R, Berger R, van Iersel TM, Smilde AK, Hankemeier T, Alkema W. Assessing the metabolic effects of prednisolone in healthy volunteers using urine metabolic profiling. Genome Med. 2012 Nov 30;4(11):94. doi: 10.1186/gm395. eCollection 2012.
PubMed 23199229Toonen EJ, Fleuren WW, Nassander U, van Lierop MJ, Bauerschmidt S, Dokter WH, Alkema W. Prednisolone-induced changes in gene-expression profiles in healthy volunteers. Pharmacogenomics. 2011 Jul;12(7):985-98. doi: 10.2217/pgs.11.34. Epub 2011 Jun 2.
PubMed 21635145
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Single-center Study Using Multiple Doses of Prednisolone to Quantify Effects on Selected Biomarkers and Assess Pharmacokinetics in Healthy Males
- ClinicalTrials.gov ID
- NCT00971724
- Acronym / sponsor ID
- P05888
- Conditions
- Insulin Resistance, Hyperglycemia, Glucose Intolerance
- Keywords
- Prednisolone, Glucocorticoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 Sep 2009 (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.
Primary objective:
- To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.
Secondary objectives:
- To describe the PK of prednisolone and PD of a series of biomarkers.
- To identify biomarkers that reflect side effects of prednisolone.
- To elucidate part of the mechanisms by which prednisolone induces metabolic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTreatment with placebo for 15 days |
| Prednisolone 7.5 mg daily | Experimental | Drug: PrednisoloneTreatment with prednisolone 7.5 mg daily for 15 days |
| Prednisolone 15 mg daily | Experimental | Drug: PrednisoloneTreatment with prednisolone 15 mg daily for 15 days |
| Prednisolone 30 mg daily | Experimental | Drug: PrednisoloneTreatment with prednisolone 30 mg daily for 15 days |
| Prednisolone 75 mg | Experimental | Drug: PrednisoloneTreatment with prednisolone 75 mg for a single day |
| Prednisolone 15 mg twice daily | Experimental | Drug: PrednisoloneTreatment with prednisolone 15 mg twice daily for a single day |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 22 < BMI < 30
- fasting glucose < 5.6 mmol/L and glucose < 7.8 mmol/L 2hr after OGTT
- able and willing to sign informed consent
- history of good physical and mental health
- subject smokes less than 5 cigarettes per day
Key exclusion criteria (8 listed)
- allergy to prednisolone
- glucocorticoid use during last 3 months prior to study
- use of any drug or substance
- history of familiar diabetes type 2
- clinically relevant history or presence of any medical disorder
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 |
|---|---|---|
| PlaceboOral administration, once daily, for 15 days | Drug | Placebo |
| PrednisoloneOral administration | Drug | Prednisolone 15 mg daily, Prednisolone 15 mg twice daily, Prednisolone 30 mg daily, Prednisolone 7.5 mg daily, Prednisolone 75 mg |
Primary outcome
To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
Time frame: Day 1 and day 15
1 secondary outcome
To describe the PK of prednisolone and PD of a series of biomarkers
Time frame: Day 1 and day 15
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 22 May 2015.
- Derived from this study: PubMed 23199229Ellero-Simatos S, Szymanska E, Rullmann T, Dokter WH, Ramaker R, Berger R, van Iersel TM, Smilde AK, Hankemeier T, Alkema W. Assessing the metabolic effects of prednisolone in healthy volunteers using urine metabolic profiling. Genome Med. 2012 Nov 30;4(11):94. doi: 10.1186/gm395. eCollection 2012.
- Derived from this study: PubMed 21635145Toonen EJ, Fleuren WW, Nassander U, van Lierop MJ, Bauerschmidt S, Dokter WH, Alkema W. Prednisolone-induced changes in gene-expression profiles in healthy volunteers. Pharmacogenomics. 2011 Jul;12(7):985-98. doi: 10.2217/pgs.11.34. Epub 2011 Jun 2.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone in people with Insulin Resistance and Hyperglycemia, run by Merck Sharp & Dohme LLC.
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 8 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone (time frame: Day 1 and day 15). 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 NCT00971724, which also lists 2 linked publications.
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 22 May 2015.