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Completed

NCT Number: NCT03023891

Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

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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Key information

Conditions

Glucocorticoids Toxicity Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center -CRC

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

Prednisone 60 mg tablet once

Other names: generic, not applicable

Primary outcomes

  1. White Blood Cell Counts

    Time frame: baseline and within 4 and 8 hours after drug administration

    White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)

  2. Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose

    Time frame: baseline and 4-8 hours after drug administration

    AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.

    Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)

  3. Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels

    Time frame: baseline and 4-8 hours after drug administration

    AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.

    Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).

  4. Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels

    Time frame: baseline and 4-8 hours after drug administration

    AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.

    C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2017
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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