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
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
YUAN Wei-jie |
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 |
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