CompletedPhase 1

Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

United States25 participantsStarted 2017-02-15

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

White Blood Cell Counts

Timeframe: baseline and within 4 and 8 hours after drug administration

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

Timeframe: baseline and 4-8 hours after drug administration

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

Timeframe: baseline and 4-8 hours after drug administration

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

Timeframe: baseline and 4-8 hours after drug administration

Trial details

NCT IDNCT03023891

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-10

Results submitted2019-11-27

View on ClinicalTrials.gov More Glucocorticoids Toxicity trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

White Blood Cell Counts

Timeframe: baseline and within 4 and 8 hours after drug administration

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

Timeframe: baseline and 4-8 hours after drug administration

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

Timeframe: baseline and 4-8 hours after drug administration

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

Timeframe: baseline and 4-8 hours after drug administration