Ketosteril Sarcopenia Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- skeletal muscle mass index (SMI)
研究概览
简要总结
The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR<60 ml/(min*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.
- •Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (< 28 kg for males, < 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (< 1.0 m/s) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (< 7.0 kg/m2 for males and < 5.7 kg/m2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.
- •Patient can walk normally.
- •Provide the written informed consent.
排除标准
- •Patients with diabetes.
- •Obese/overweight patients (body mass index>25 kg/m2)
- •Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
- •Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
- •Patients with acute infection (C-reactive protein>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months.
- •Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.
- •Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.
- •Patients with hypercalcemia and amino acid metabolism disorder.
- •Those who are allergic to the active ingredients or other excipients of the Ketosteril.
- •Patients with poor compliance, unable to follow the study requirements for diet control.
- •Participated in other interventional clinical trials within 30 days before this study.
研究组 & 干预措施
Intervention
In the intervention group, low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.
干预措施: low-protein diet + Ketosteril (Combination Product)
Control
In the control group, low-protein diet (0.6-0.8g protein/kg body weight/day) and the target energy intake of 25-30kcal/kg body weight/day will be prescribed for 9 months
干预措施: low-protein diet (Dietary Supplement)
结局指标
主要结局
skeletal muscle mass index (SMI)
时间窗: six months after the intervention
SMI=skeletal muscle weight/(height×height)，the muscle weight with the unit of kg and square of height with the unit of m2 will be combined to report SMI in kg/m\^2
次要结局
- serum albumin(g/l)(six months after the intervention)
- BMI(kg/m2)(six months after the intervention)
- 6m walking speed(s)(six months after the intervention)
- grip strength(kg)(six months after the intervention)
- changes in eGFR(ml/min/1.73m2)(six months after the intervention)
研究者
Chen Jing
Director of Nephrology
Huashan Hospital