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| ID | Type | Description | Link |
|---|---|---|---|
| 294001 | Other Identifier | Merck |
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Primary objective:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Treatment with placebo for 15 days |
|
| Prednisolone 7.5 mg daily | Experimental | Treatment with prednisolone 7.5 mg daily for 15 days |
|
| Prednisolone 15 mg daily | Experimental | Treatment with prednisolone 15 mg daily for 15 days |
|
| Prednisolone 30 mg daily | Experimental | Treatment with prednisolone 30 mg daily for 15 days |
|
| Prednisolone 75 mg | Experimental | Treatment with prednisolone 75 mg for a single day |
|
| Prednisolone 15 mg twice daily | Experimental | Treatment with prednisolone 15 mg twice daily for a single day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral administration, once daily, for 15 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone | Day 1 and day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the PK of prednisolone and PD of a series of biomarkers | Day 1 and day 15 |
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Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23199229 | Derived | 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. | |
| 21635145 | Derived |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006943 | Hyperglycemia |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Prednisolone |
| Drug |
Oral administration |
|
| Toonen 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. |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |