Does Protein Restriction Plus Essential Amino Acids and Keto-analogues Supplementation Have a Beneficial Effect on GFR Decline in CKD Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- GFR decline
研究概览
简要总结
This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients.
详细描述
In chronic kidney disease (CKD) patients, ketoacid analogues of essential amino acids (KA/EAA) are administered to reduce the production of harmful metabolic products and enhance nutritional status. Protein restriction combined with AA supplement may have beneficial effects on CKD in several ways, by reducing nitrogen waste, oxidative stress, and inflammation, and by protecting against hemodynamic changes in glomerular hyperfiltration.
several clinical trials have documented that very low protein diets (VLPD) supplemented with KA/EAA preserve the rate of progression of advanced CKD. However, in long-term follow-up of the MDRD study, VLPD plus KA/EAA treatment did not delay progression to dialysis or transplantation.
As a result, no firm conclusions have been drawn on the effectiveness of protein-restricted diets combined with KA/EAA supplements in retarding CKD progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with CKD stages (G2 to G4), aged ≥ 18 years old
排除标准
- •Active malignancy
- •Protein energy wasting
- •Advanced organ disease
研究组 & 干预措施
control group
include patients who were on low protein diet only
干预措施: low protein diet (Other)
interventional group
include patients who consumed KA/EAA plus very low protein diet
干预措施: essential amino acids and keto-analogues supplementation (Drug)
结局指标
主要结局
GFR decline
时间窗: 24 months
effect on GFR change at one year from baseline in CKD patients
次要结局
- effect on calcium(24 months)
- effect on albumin(24 months)
研究者
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Lecturer
Alexandria University