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

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ClinicalTrials.gov Identifier: NCT02568020
Recruitment Status : Unknown
Verified October 2016 by YUAN Wei-jie, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
YUAN Wei-jie, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Muscular Atrophy Drug: keto-amino acids Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
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 Name: Ketosteril®(Fresenius Kabi)




Primary Outcome Measures :
  1. Body weight assessment [ Time Frame: 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.

  2. skeletal muscle mass [ Time Frame: 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.

  3. Quadriceps strength assessment [ Time Frame: 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.

  4. Knee and hip extension power assessment [ Time Frame: 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).

  5. Fatigability assessment [ Time Frame: 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.

  6. Height assessment [ Time Frame: 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


Secondary Outcome Measures :
  1. Dietary assessment [ Time Frame: 1 year ]
    The composition of the diet will be evaluated through questionnaire

  2. computer-based nutritional assessment [ Time Frame: 1 year ]
    analyzed a computer-based nutritional evaluation with Dieta software.

  3. Biochemical data [ Time Frame: 1 year ]
    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.

  4. calculate HOMA-IR [ Time Frame: 1 year ]
    Homeostatic model assessment score (HOMA-IR) was recorded.

  5. Safety parameters [ Time Frame: 1 year ]
    Blood routine:including WBC, RBC, Hb, PLT, HCT; Blood biochemistry:including Ca, P, iPTH, albumin, prealbumin, transferrin, creatinine, Bun,CRP Blood fat: cholesterol, triglyceride(VLDL、LDL、HDL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: YUAN Wei-jie, chief physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02568020    
Other Study ID Numbers: Keto-019-IP3
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases