Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids



Status:Active, not recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 45
Updated:2/27/2019
Start Date:February 15, 2017
End Date:December 31, 2019

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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.

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
We found this trial at
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Nashville, Tennessee 37203
Phone: 615-322-3778
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