Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Glucose Area Under the Curve (AUC)
研究概览
简要总结
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
详细描述
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.
This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
- •Fasting glucose 100-125 mg/dL
- •18 years and older
排除标准
- •Diagnosed with diabetes mellitus
- •Use of diabetes medications (insulin or oral hypoglycemics)
- •Prior dialysis or transplantation
- •Planning to leave the area within 6 months
- •Participation in another clinical trial within 30 days
- •Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
- •Serum calcium more than 10.2 mg/dL
- •Pregnancy or breast-feeding
- •Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol
- •Incontinent of urine
- •Cancer (other than skin cancer) within 5 years
- •Tuberculosis
- •Sarcoidosis
研究组 & 干预措施
Paricalcitol followed by placebo
Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
干预措施: Paricalcitol (Drug)
Paricalcitol followed by placebo
Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
干预措施: Placebo (Drug)
Placebo followed by paricalcitol
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
干预措施: Paricalcitol (Drug)
Placebo followed by paricalcitol
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Glucose Area Under the Curve (AUC)
时间窗: 8 weeks
Glucose AUC during a 2-hour oral glucose tolerance test
次要结局
未报告次要终点
研究者
Ian deBoer
Professor
University of Washington