Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Primary Purpose
Glucocorticoids Toxicity, Glucose Intolerance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional other trial for Glucocorticoids Toxicity focused on measuring glucocorticoids, efficacy, metabolic toxicity
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center -CRC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prednisone
Arm Description
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
Outcomes
Primary Outcome Measures
White Blood Cell Counts
White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)
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)
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).
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03023891
First Posted
January 12, 2017
Last Updated
May 25, 2020
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT03023891
Brief Title
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Official Title
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucocorticoids Toxicity, Glucose Intolerance
Keywords
glucocorticoids, efficacy, metabolic toxicity
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
generic, not applicable
Intervention Description
Prednisone 60 mg tablet once
Primary Outcome Measure Information:
Title
White Blood Cell Counts
Description
White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)
Time Frame
baseline and within 4 and 8 hours after drug administration
Title
Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
Description
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)
Time Frame
baseline and 4-8 hours after drug administration
Title
Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
Description
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).
Time Frame
baseline and 4-8 hours after drug administration
Title
Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
Description
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)
Time Frame
baseline and 4-8 hours after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian K Kawai
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center -CRC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
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