Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

NCT03023891 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 1619425K23GM117395-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glucocorticoids Toxicity; Glucose Intolerance

Keywords

glucocorticoids; efficacy; metabolic toxicity

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Prednisone

EXPERIMENTAL

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

Drug: Prednisone

Interventions

Prednisone DRUG

Prednisone 60 mg tablet once

Also known as: generic, not applicable

Prednisone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Vanderbilt University Medical Center -CRC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Prednisone; Drugs, Generic

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pharmaceutical Preparations

Results Point of Contact

• Title: Vivian Kawai
• Organization: Vanderbilt University Medical Center

vivian.k.kawai@vumc.org

(615) 322-3304

Study Officials

• Vivian K Kawai

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 18, 2017
• Study Start: February 15, 2017
• Primary Completion: January 10, 2019
• Study Completion: December 31, 2019
• Last Updated: June 4, 2020
• Results First Posted: January 6, 2020

Record last verified: 2020-05

Locations

US (1)