Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: Glucocorticoids; Prednisone

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