Trial | NCT02568020  Report issue

Title

LPD+α-ketoacids on Autophagy and Improving Muscle Wasting in CKD
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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.
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.
Study Started
Nov 30
2016
Primary Completion
Dec 31
2018
Anticipated
Study Completion
May 31
2019
Anticipated
Last Update
Nov 01
2016
Estimate

Drug keto-amino acids

Ketosteril®( Fresenius Kabi) will be given 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.

  • Other names: Ketosteril®(Fresenius Kabi)

low-protein diet(LPD) No Intervention

All patients will be treated with a LPD containing 0.6g protein/kg BW per day and 120-125 kJ/kg BW per day.The patients will be followed-up for one year. The patients will come to the hospital every 4 weeks.

LPD+KA Experimental

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.

Criteria 

Inclusion Criteria:

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.

Exclusion Criteria:

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.
No Results Posted