Phase 1
Completed N=18
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Glucocorticoids Toxicity · Glucose Intolerance
Source: ClinicalTrials.gov NCT03023891 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: White Blood Cell Counts — 5.26; 6.99 x10^3 cells/mL
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. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY White Blood Cell Counts |
5.26; 6.99 | — |
| PRIMARY Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose |
13530.56; 20273.75 | — |
| PRIMARY Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels |
5415.87; 5466.55 | — |
| PRIMARY Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels |
493.89; 449.41 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03023891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.