Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glucocorticoids Toxicity Glucose Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prednisone

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

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Prednisone 60 mg tablet once

Interventions

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Prednisone

Prednisone 60 mg tablet once

Intervention Type DRUG

Other Intervention Names

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generic, not applicable

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes