Clinical trial NCT02568020: LPD+α-ketoacids on Autophagy and Improving Muscle Wasting in CKD
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Muscular Atrophy
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 1. Dietary assessment: The composition of the diet will be evaluated through questionnaire, and analyzed a computer-based nutritional evaluation with Dieta software.
2. 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.
3. 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.

Eligibility 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.

Primary outcomes:
measure: Body weight assessment
timeFrame: 1 year
measure: skeletal muscle mass
timeFrame: 1 year
measure: Quadriceps strength assessment
timeFrame: 1 year
measure: Knee and hip extension power assessment
timeFrame: 1 year
measure: Fatigability assessment
timeFrame: 1 year
measure: Height assessment
timeFrame: 1 year
Secondary outcomes:
measure: Dietary assessment
timeFrame: 1 year
measure: computer-based nutritional assessment
timeFrame: 1 year
measure: Biochemical data
timeFrame: 1 year
measure: calculate HOMA-IR
timeFrame: 1 year
measure: Safety parameters
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang Y, Gu L, Wang L, Rong S, Yuan W. Low protein diet supplemented with ketoacids on muscle wasting in chronic kidney disease: A clinical trial. Front Med (Lausanne). 2022 Aug 30;9:949108. doi: 10.3389/fmed.2022.949108. eCollection 2022.