Protein metabolism in chronic kidney disease
ISRCTN | ISRCTN64383094 |
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DOI | https://doi.org/10.1186/ISRCTN64383094 |
Secondary identifying numbers | N/A |
- Submission date
- 18/01/2013
- Registration date
- 21/02/2013
- Last edited
- 22/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Protein-energy wasting (PEW) is common in patients with chronic kidney disease. It is a condition where the body has decreased stores of protein and energy and is associated with an increased risk of death. The aim of this study is to investigate the response to a low protein diet and a keto/amino acid supplemented very low protein diet in patients with chronic kidney disease.
Who can participate?
Patients aged 18 to 79 with chronic kidney disease
What does the study involve?
The study is composed of two different studies. In study A participants eat a usual-protein diet followed by a low-protein diet to find out how skeletal muscle protein turnover adapts. Study B consists of four six-week periods: the enrollment period, a low-protein diet period, a keto/amino acid supplemented very low protein diet period, and another low-protein diet period. Protein turnover (both whole body and muscle) is measured at the start of the study and at the end of each six-week period.
What are the possible benefits and risks of participating?
The study provides new information on how the body adapts to a low protein diet, and may be helpful for the understanding of their nutritional safety. The study involves the use of stable isotopes of naturally occurring amino acids, a procedure which is not harmful. The possible risks of measuring muscle protein turnover are those related to cannulation (where a tube is inserted into a blood vessel).
Where is the study run from?
Università degli studi di Genova (Italy)
When is the study starting and how long is it expected to run for?
January 2013 to June 2014
Who is funding the study?
Fresenius Kabi (Germany)
Who is the main contact?
Prof. Giacomo Garibotto
gari@unige.it
Contact information
Scientific
Viale Benedetto xv
Genoa
16132
Italy
gari@unige.it |
Study information
Study design | Non-randomized prospective self-controlled crossover trial |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Effects of a low protein diet and of a keto/amino acid supplemented very low protein diet on muscle protein metabolism and myostatin in patients with chronic kidney disease |
Study acronym | PMCKD |
Study objectives | The hypothesis is that the use of keto/amino acid supplements may partially or totally reverse the abnormal amino acid metabolism thus counteracting the uremia-related muscle cell loss and catabolic events. |
Ethics approval(s) | IRCCS Azienda Ospedaliera Universitaria San Martino- IST Istituto Nazionale per la Ricerca sul Cancro, 13/04/2012, ref: 7/2012 |
Health condition(s) or problem(s) studied | Chronic kidney disease |
Intervention | Low protein diet or supplemented very low protein dieT (vLPD) The research protocol is composed of two different studies: Study A: to determine how skeletal muscle protein metabolism adapt to a low protein diet, forearm protein turnover will be evaluated in the same CKD patients assigned to a usual-protein diet (1.1 g/kg/day, 30-35 kcalday), followed by a low-protein diet (LPD) (0.8 g/kg, followed by 0.55 g/kg, 30-35 kcal/Kg/day). Each time period of study is 6 weeks, with total length of period of time during which patient will be followed up of 18-24 weeks. To determine the muscle responses to a supplemented vLPD (0,45 g/kg, supplemented with 0.1 g/kg Ketosteril, 30-35 kcal/Kg/day) Study B: protein turnover (both whole body and muscle), muscle and plasma myostatin, muscle apoptosis, muscle proteolytic-related genes and intracellular insulin signaling, will be studied in a prospective cross-over trial with CKD patients serving as their own controls. Study B consists of four six-week consecutive periods: the enrollment period, the baseline (LPD) period, the treatment period (supplemented protein-restricted, vLPD) and the wash-out LPD period . |
Intervention type | Other |
Primary outcome measure | Protein metabolism measured at baseline and at the end of each six-week experimental period |
Secondary outcome measures | Serum/muscle myostatin measured at baseline and at the end of each six-week experimental period |
Overall study start date | 10/01/2013 |
Completion date | 06/06/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 79 Years |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | 1. Aged 18-79, both males and females 2. Non-diabetic CKD (Stages 4-5, estimated glomerular filtration rate [eGFR] 12-25 ml/min) 3. Compliance to treatment |
Key exclusion criteria | 1. Evidence of congestive heart failure 2. Incapable of following study requirements to control diet 3. A recent myocardial infarction 4. Pregnancy 5. Unstable renal function 6. Recent (<3 months) infection history 7. Clinical evidence of gastrointestinal or liver diseases 8. Alcoholism 9. Drug abuse 10. Final diagnosis of malignancy |
Date of first enrolment | 10/01/2013 |
Date of final enrolment | 06/06/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
16132
Italy
Sponsor information
Industry
Else-Kröner-Str.1
Bad Homburg
61346
Germany
Anja.Markant@fresenius-kabi.com | |
Website | http://www.fresenius-kabi.com/ |
https://ror.org/01v376g59 |
Funders
Funder type
Industry
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
22/06/2017: Plain English summary added.