Glucose Intolerance Clinical Trial
Official title:
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Verified date | May 2020 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center -CRC | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Institute of General Medical Sciences (NIGMS) |
United States,
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 |
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