Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

Glucose Intolerance Clinical Trial

Official title:

Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023891
• Other study ID #: 161942
• Secondary ID: 5K23GM117395-03
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucocorticoids Toxicity
• Glucose Intolerance

Intervention

Drug:
• Prednisone
Prednisone 60 mg tablet once

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center -CRC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	White Blood Cell Counts	White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)	baseline and within 4 and 8 hours after drug administration
Primary	Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose	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)	baseline and 4-8 hours after drug administration
Primary	Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels	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).	baseline and 4-8 hours after drug administration
Primary	Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels	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)	baseline and 4-8 hours after drug administration