NCT00656032已完成2 期
Vitamin D, Insulin Resistance and Inflammation in ESRD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- An improvement in insulin sensitivity
研究概览
简要总结
The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD and receiving hemodialysis for ≥ 3months
- •Kt/V ≥ 1.2
- •≥ 18 years of age
- •Medically stable
- •AVF or PTFE dialysis access
- •No acute inflammatory disease within 4 weeks prior to the study
- •On stable dose of Paricalcitol for 4 weeks prior to the study
- •iPTH value between 150 - 1500 within the past 3 months
- •Ca < 10.5
- •PO4 < 10
排除标准
- •Pregnancy
- •Intolerance to the study medication
- •Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
- •Type 1 Diabetes mellitus
- •Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10)
- •Hospitalization within 1 month prior to the study
- •Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 250 ml/min)
- •Presence of hemodialysis catheter
- •Patients receiving steroids and/or other immunosuppressive agents (> 10 mg prednisone qd)
- •BMI < 25 and > 45
结局指标
主要结局
An improvement in insulin sensitivity
时间窗: 8 weeks
次要结局
- A change in insulin signaling(8 weeks)
- A decrease in concentration of plasma pro-inflammatory cytokines(8 weeks)
研究者
Alp Ikizler
Professor
Vanderbilt University
研究点 (2)
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