Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- White Blood Cell Counts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Prednisone
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
干预措施: Prednisone (Drug)
结局指标
主要结局
White Blood Cell Counts
时间窗: baseline and within 4 and 8 hours after drug administration
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
时间窗: baseline and 4-8 hours after drug administration
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
时间窗: baseline and 4-8 hours after drug administration
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
时间窗: baseline and 4-8 hours after drug administration
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)
次要结局
未报告次要终点
研究者
Vivian Kawai
Research Assistant Professor
Vanderbilt University Medical Center