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

NCT ID: NCT02568020

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-05-31

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.

Conditions

Muscular Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

low-protein diet(LPD)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

keto-amino acids

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ketosteril®(Fresenius Kabi)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YUAN Wei-jie

OTHER

Sponsor Role: lead

Responsible Party

YUAN Wei-jie

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 36186800 (View on PubMed)

Other Identifiers

Keto-019-IP3

Identifier Type: -

Identifier Source: org_study_id