Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

Vanderbilt University Medical Center

Status and phase: Completed; Phase 1

Conditions: Glucocorticoids Toxicity; Glucose Intolerance

Treatments: Drug: Prednisone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03023891

5K23GM117395-03 (U.S. NIH Grant/Contract)

161942

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

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 glucocorticoids (within the last year);
• Pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Prednisone

Experimental group

Description:

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

Treatment:

Drug: Prednisone