Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
The overarching aim of this proposal is to examine the effects of usual protein diet supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis (PD). The investigators will achieve this goal through a randomized controlled trial of administration of usual protein diet plus KA versus usual protein diet alone in patients on peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study will provide potential avenues for improvement of metabolic profile of patients on PD and possibly improve long-term outcomes such as cardiovascular disease risk and death.
详细描述
Specific Aims and Significance:
To evaluate the effects of KA plus usual protein diet on basal and stimulated insulin sensitivity in PD patients.
Hypothesis: Administration of KA plus usual protein diet will improve insulin resistance in peritoneal dialysis patients.
To evaluate the influence of KA plus usual protein diet on non-traditional cardiovascular disease (CVD) markers (markers of inflammation and oxidative stress) in PD patients.
Hypothesis: Administration of KA plus usual protein diet will improve markers of inflammation and oxidative stress in PD 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medically stable and receiving stable PD >= 3 months
- •age 18-80 years
- •body mass index > 18.5
- •Kt/v >= 1.7 or Tccr >= 50l/week/1.73m2
- •glucose lactate-buffered PD solutions
排除标准
- •pregnancy
- •intolerance to the study protocols
- •severe, unstable, active, or chronic inflammation disease
- •chronic use of anti-inflammatory medication
- •severe malnutrition
- •a high probability of receiving a kidney transplant or transferring to HD within 6 months
- •taking anti-inflammatory medication chronically or taking KA during the past one month
研究组 & 干预措施
Keto Acid supplemented with usual protein diet
干预措施: Keto Acid (Drug)
结局指标
主要结局
Insulin resistance
时间窗: at 0, 12, 24 week after patients start their study prescription
Insulin sensitivity will be measured using HOMA-IR.
次要结局
- Inflammatory state(at 0, 12, 24 week after patients start their study prescription)
- Oxidative stress(at 0, 12, 24 week after patients start their study prescription)
- Endothelial dysfunction(at 0, 12, 24 week after patients start their study prescription)
研究者
Dong Jie
Institute of Nephrology, Division of Renal
Peking University First Hospital