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Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids (NCT03023891)

National Institute of General Medical Sciences (NIGMS)
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.
  • Drug: Prednisone
    Prednisone 60 mg tablet once
    • generic, not applicable
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 GCs (within the last year);
  • Pregnancy
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.

1 locations

United States (1)
  • Vanderbilt University Medical Center -CRC
    recruiting
    Nashville, Tennessee, United States, 37203
Status:
recruiting
Type:
Interventional
Phase:
Start:
14 February, 2017
Updated:
12 June, 2017
Participants:
50
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