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 range

18 Years – 45 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 45 Years

Sex

ALL

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