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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23GM117395-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone 60 mg tablet once |
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| Measure | Description | Time Frame |
|---|---|---|
| White Blood Cell Counts | White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2) | 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) | 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). | 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) | baseline and 4-8 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivian K Kawai | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center -CRC | Nashville | Tennessee | 37203 | United States |
25 participants signed consent, 5 did not show up for screening and 2 failed screening. 18 participants started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | White Blood Cell Counts | White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2) | Posted | Mean | Standard Deviation | x10^3 cells/mL | baseline and within 4 and 8 hours after drug administration |
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2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone | 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 60 mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug Prednisone: Prednisone 60 mg tablet once |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Kawai | Vanderbilt University Medical Center | (615) 322-3304 | vivian.k.kawai@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2018 | Nov 25, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2017 | Nov 26, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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) | Posted | Mean | Standard Deviation | mg*min/dL | baseline and 4-8 hours after drug administration |
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| Primary | 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). | Posted | Mean | Standard Deviation | μU*min/mL | baseline and 4-8 hours after drug administration |
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| Primary | 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) | Posted | Mean | Standard Deviation | ng*min/mL | baseline and 4-8 hours after drug administration |
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| 0 |
| 18 |
| 0 |
| 18 |
| 4 |
| 18 |
| Mild Dizziness | General disorders | Non-systematic Assessment |
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| Mild anxiety and hyperactivity | General disorders | Non-systematic Assessment |
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| Tiredness, Fatigue | General disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004364 | Pharmaceutical Preparations |