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

Muscular Atrophy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02568020
• Other study ID #: Keto-019-IP3
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 30, 2015
• Last updated: October 31, 2016
• Start date: November 2016
• Est. completion date: May 2019

Study information

• Verified date: October 2016
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
YUAN Wei-jie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight assessment	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.	1 year	Yes
Primary	skeletal muscle mass	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.	1 year	Yes
Primary	Quadriceps strength assessment	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.	1 year	Yes
Primary	Knee and hip extension power assessment	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).	1 year	Yes
Primary	Fatigability assessment	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.	1 year	Yes
Primary	Height assessment	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	1 year	Yes
Secondary	Dietary assessment	The composition of the diet will be evaluated through questionnaire	1 year	Yes
Secondary	computer-based nutritional assessment	analyzed a computer-based nutritional evaluation with Dieta software.	1 year	Yes
Secondary	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.	1 year	Yes
Secondary	calculate HOMA-IR	Homeostatic model assessment score (HOMA-IR) was recorded.	1 year	Yes
Secondary	Safety parameters	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)	1 year	Yes