- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02568020
LPD+α-ketoacids on Autophagy and Improving Muscle Wasting in CKD
October 31, 2016 updated by: YUAN Wei-jie
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.
Study Overview
Detailed Description
- Dietary assessment: The composition of the diet will be evaluated through questionnaire, and analyzed a computer-based nutritional evaluation with Dieta software.
- 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.
- 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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
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).
|
1 year
|
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.
|
1 year
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary assessment
Time Frame: 1 year
|
The composition of the diet will be evaluated through questionnaire
|
1 year
|
computer-based nutritional assessment
Time Frame: 1 year
|
analyzed a computer-based nutritional evaluation with Dieta software.
|
1 year
|
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.
|
1 year
|
calculate HOMA-IR
Time Frame: 1 year
|
Homeostatic model assessment score (HOMA-IR) was recorded.
|
1 year
|
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)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
September 30, 2015
First Submitted That Met QC Criteria
September 30, 2015
First Posted (Estimate)
October 5, 2015
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 31, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Keto-019-IP3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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