Mechanisms of Low Protein Diet Supplemented With α-ketoacids on Autophagy and Improving Muscle Wasting in Chronic Kidney Disease: the Role of Autophagy in Muscle Wasting
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Quadriceps strength assessment
研究概览
简要总结
To investigate the effects of different dietary regimens on muscle wasting, insulin/IGF-1 resistance. Further, to explore whether LPD+KA decrease the activation of autophagy associate with insulin/IGF-1 pathway.
详细描述
- Dietary assessment: The composition of the diet will be evaluated through questionnaire, and analyzed a computer-based nutritional evaluation with Dieta software.
- Biochemical data: blood samples will be collected at baseline and every 3 months of routine examination, such as blood routine, biochemistry, HbA1c, Serum IGF-1, CRP, will be measured. Homeostatic model assessment score (HOMA-IR) was recorded.
- Skeletal muscle assessment: the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Body weight, height, Body mass index, skeletal muscle mass will be measured by Body composition analyzer. Quadriceps strength will be assessed with a seated leg press exercise instrument (Keiser Sport, Fresno, CA, USA) using the five repetition maximum technique. Knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (University ofNottingham Medical College, Nottingham, UK). Fatigability will be assessed with the same bilateral leg press exercise used in strength testing.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients agree to participate in this study; age≥18 years and<70years; renal function measured with creatinine clearance<60 and >15 ml/min (three monthly consecutive measurements)；at least 6 months of follow up at our clinic before recruitment and haven't received any diet intervention.
排除标准
- •pregnant patients; diabetes; heart or liver failure; a recent myocardial infarction (in the last 12 months); long term immobilization; chronic respiratory failure; cancer; any pharmacological treatment that could modify muscle structure or function such as glucocorticoids or insulin；Contraindications of Ketosteril, such as hypersensitivity to the active substances or to any of the excipients, hypercalcaemia, disturbed amino acid metabolism to the study protocol.
研究组 & 干预措施
LPD+KA
LPD+KA group will be supplemented with keto-amino acids (Ketosteril®, Fresenius Kabi) at a dosage of one tablet/5kg ideal body weight/day, divided into three doses taken during meals.The patients will be followed-up for one year. The patients will come to the hospital every 4 weeks.
干预措施: keto-amino acids (Drug)
结局指标
主要结局
Quadriceps strength assessment
时间窗: 1 year
the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Quadriceps strength will be assessed with a seated leg press exercise instrument (Keiser Sport, Fresno, CA, USA) using the five repetition maximum technique.
Body weight assessment
时间窗: 1 year
the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Body weight will be measured to calculate Body mass index.
Knee and hip extension power assessment
时间窗: 1 year
the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (University ofNottingham Medical College, Nottingham, UK).
Fatigability assessment
时间窗: 1 year
the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Fatigability will be assessed with the same leg power instrument (University ofNottingham Medical College, Nottingham, UK) as used in strength testing.
Height assessment
时间窗: 1 year
the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Height will be measured to calculate Body mass index
skeletal muscle mass
时间窗: 1 year
the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. muscle circumference including mid-arm, mid-thigh, and mid-calf circumferences will be assessed.
次要结局
- computer-based nutritional assessment(1 year)
- Dietary assessment(1 year)
- calculate HOMA-IR(1 year)
- Biochemical data(1 year)
- Safety parameters(1 year)
研究者
YUAN Wei-jie
chief physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine