Chronic Kidney DiseasesNCT03171116
Ghrelin and Obestatin in CKD Children
An observational study of Chronic Kidney Diseases, run by Azienda Ospedaliero Universitaria Maggiore della Carita.
Trial summary
Protein energy wasting (PEW) is a complex syndrome associated with different underlying illnesses and characterized by loss of muscle, with or without loss of fat. It is a highly prevalent condition among patients with chronic kidney disease (CKD), associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- none intervention
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 154 subjects were included (M:F=100:54), 111 patients and 43 controls. Out of 111 patients, 43 had CKD stages II-V under conservative treatment (CKD-CT), 20 were on hemodialysis (CKD-HD), 48 were renal transplant recipients (RTx).
Who may be able to join
- the CKD-HD patients should have been on hemodialysis treatment for at least 3 months
- the RTx patients should have received renal transplantation at least 6 months before
Who cannot join
- treatment with growth hormone
- the presence of neurologic disability or syndromic diseases affecting per se food intake
- for controls: they should have no history of chronic diseases and should not receive any medication. They should be on unrestricted diet.
About this study
Official title: Unacylated Ghrelin and Obestatin as Promising Biomarkers of Protein Energy Wasting in Children With Chronic Kidney Disease: a Cross-sectional Case-control Study
Protein energy wasting (PEW) is a complex syndrome associated with different underlying illnesses and characterized by loss of muscle, with or without loss of fat. It is a highly prevalent condition among patients with chronic kidney disease (CKD), associated with increased morbidity and mortality.
The pathophysiology of PEW in CKD is multifactorial and not yet completely understood. The potential role in uremic PEW of two of hormones involved in orexigenic/anorexigenic balance, ghrelin and obestatin, both derived from the ghrelin gene (GHRL), has been investigated in adults and, less extensively, in children. Aim of our study was to measure AG, UAG and obestatin concentrations in children with CKD and to assess their potential contribution to the development of pediatric uremic PEW.
Read the detailed description
This is a cross-sectional case-control study. Between January 2013 and June 2015 children and adolescents aged 5-20 years, referred to the Pediatric Nephrology, Dialysis and Transplant Unit of Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Milan, Italy were enrolled. Subjects with CKD stages II-V under conservative treatment (CKD-CT), or undergoing hemodialysis treatment (CKD-HD), or being renal transplant recipients (RTx) were included in the study. Data about age, primary renal disease and concomitant medications were collected for each subject.
CKD stages were defined using the K/DOQI criteria of the US National Kidney Foundation.
Control subjects were outpatients of the Pediatric Surgery Unit of the Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Milan, Italy, aged 1-20 years, who underwent a blood sample collection before a surgical intervention for the treatment of minor diseases that did not impair renal or endocrine function (i.e. phimosis, hydrocele, inguinal hernia).
Biochemical and hormonal parameters Blood samples were collected between 7:00 and 8:00 a.m. after an overnight fast, and before dialysis in CKD-HD patients. Routine biochemical parameters [creatinine, urea] were measured in all subjects. Glomerular filtration rate was estimated (eGFR) by the Schwartz formula, with k = 0.413, as appropriate for standardized creatinine.
In all subjects, plasma AG and UAG concentrations were measured by the Human Acylated / Unacylated Ghrelin ELISA kit (BioVendor, Laboratorni Medicina a.s., Brno, Czech Republic) according to manufacture procedures, and AG/UAG ratio was calculated. Serum obestatin concentrations were determined using the Human Obestatin ELISA kit (BioVendor, Laboratorni Medicina a.s., Brno, Czech Republic).
- Conditions
- Chronic Kidney Diseases
- Being tested
- none intervention
- Keywords
- ghrelin, obestatin, children
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
it is not an interventional study; it is an observational study
| Study group | Role | What they receive |
|---|---|---|
| CKD-CT | subjects with CKD stages II-V under conservative treatment Receives: Other: none intervention | |
| CKD-HD | subjects with CKD stage V on hemodialysis Receives: Other: none intervention | |
| RTx renal transplant | renal transplant recipients Receives: Other: none intervention | |
| Controls | control subjects Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
AG concentrations by ELISA kit on plasma samples
Acyl-ghrelin measurement
Measured: January 2013-June 2015
UAG concentrations by ELISA kit on plasma samples
Unacyl-ghrelin measurement
Measured: January 2013-June 2015
Obestatin concentrations by ELISA kit on serum samples
Obestatin measurement
Measured: January 2013-June 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jan 2013
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Flavia Prodam, MD, Study director, Università del Piemonte Orientale - Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171116
- Sponsor's protocol ID
- 396/2011 bis
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mak RH, Ikizler AT, Kovesdy CP, Raj DS, Stenvinkel P, Kalantar-Zadeh K. Wasting in chronic kidney disease. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):9-25. doi: 10.1007/s13539-011-0019-5. Epub 2011 Mar 16.
PubMed 21475675Perez-Fontan M, Cordido F, Rodriguez-Carmona A, Peteiro J, Garcia-Naveiro R, Garcia-Buela J. Plasma ghrelin levels in patients undergoing haemodialysis and peritoneal dialysis. Nephrol Dial Transplant. 2004 Aug;19(8):2095-100. doi: 10.1093/ndt/gfh313. Epub 2004 Jun 8.
PubMed 15187192Iglesias P, Diez JJ, Fernandez-Reyes MJ, Codoceo R, Alvarez-Fidalgo P, Bajo MA, Aguilera A, Selgas R. Serum ghrelin concentrations in patients with chronic renal failure undergoing dialysis. Clin Endocrinol (Oxf). 2006 Jan;64(1):68-73. doi: 10.1111/j.1365-2265.2005.02418.x.
PubMed 16402931Barazzoni R, Zanetti M, Stulle M, Mucci MP, Pirulli A, Dore F, Panzetta G, Vasile A, Biolo G, Guarnieri G. Higher total ghrelin levels are associated with higher insulin-mediated glucose disposal in non-diabetic maintenance hemodialysis patients. Clin Nutr. 2008 Feb;27(1):142-9. doi: 10.1016/j.clnu.2007.06.013. Epub 2007 Sep 12.
PubMed 17854954Jarkovska Z, Hodkova M, Sazamova M, Rosicka M, Dusilova-Sulkova S, Marek J, Justova V, Lacinova Z, Haluzik M, Haas T, Krsek M. Plasma levels of active and total ghrelin in renal failure: a relationship with GH/IGF-I axis. Growth Horm IGF Res. 2005 Dec;15(6):369-76. doi: 10.1016/j.ghir.2005.07.004. Epub 2005 Sep 28.
PubMed 16198134Yoshimoto A, Mori K, Sugawara A, Mukoyama M, Yahata K, Suganami T, Takaya K, Hosoda H, Kojima M, Kangawa K, Nakao K. Plasma ghrelin and desacyl ghrelin concentrations in renal failure. J Am Soc Nephrol. 2002 Nov;13(11):2748-52. doi: 10.1097/01.asn.0000032420.12455.74.
PubMed 12397045Mafra D, Guebre-Egziabher F, Cleaud C, Arkouche W, Mialon A, Drai J, Fouque D. Obestatin and ghrelin interplay in hemodialysis patients. Nutrition. 2010 Nov-Dec;26(11-12):1100-4. doi: 10.1016/j.nut.2009.09.003. Epub 2009 Dec 16.
PubMed 20018486Buscher AK, Buscher R, Hauffa BP, Hoyer PF. Alterations in appetite-regulating hormones influence protein-energy wasting in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2010 Nov;25(11):2295-301. doi: 10.1007/s00467-010-1588-9. Epub 2010 Jul 6.
PubMed 20607302Nusken KD, Groschl M, Rauh M, Stohr W, Rascher W, Dotsch J. Effect of renal failure and dialysis on circulating ghrelin concentration in children. Nephrol Dial Transplant. 2004 Aug;19(8):2156-7. doi: 10.1093/ndt/gfh310. No abstract available.
PubMed 15252183Arbeiter AK, Buscher R, Petersenn S, Hauffa BP, Mann K, Hoyer PF. Ghrelin and other appetite-regulating hormones in paediatric patients with chronic renal failure during dialysis and following kidney transplantation. Nephrol Dial Transplant. 2009 Feb;24(2):643-6. doi: 10.1093/ndt/gfn529. Epub 2008 Sep 22.
PubMed 18809976Monzani A, Perrone M, Prodam F, Moia S, Genoni G, Testa S, Paglialonga F, Rapa A, Bona G, Montini G, Edefonti A. Unacylated ghrelin and obestatin: promising biomarkers of protein energy wasting in children with chronic kidney disease. Pediatr Nephrol. 2018 Apr;33(4):661-672. doi: 10.1007/s00467-017-3840-z. Epub 2017 Nov 18.
PubMed 29150712
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unacylated Ghrelin and Obestatin as Promising Biomarkers of Protein Energy Wasting in Children With Chronic Kidney Disease: a Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT03171116
- Acronym / sponsor ID
- 396/2011 bis
- Conditions
- Chronic Kidney Diseases
- Keywords
- ghrelin, obestatin, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protein energy wasting (PEW) is a complex syndrome associated with different underlying illnesses and characterized by loss of muscle, with or without loss of fat. It is a highly prevalent condition among patients with chronic kidney disease (CKD), associated with increased morbidity and mortality.
The pathophysiology of PEW in CKD is multifactorial and not yet completely understood. The potential role in uremic PEW of two of hormones involved in orexigenic/anorexigenic balance, ghrelin and obestatin, both derived from the ghrelin gene (GHRL), has been investigated in adults and, less extensively, in children. Aim of our study was to measure AG, UAG and obestatin concentrations in children with CKD and to assess their potential contribution to the development of pediatric uremic PEW.
Detailed description
This is a cross-sectional case-control study. Between January 2013 and June 2015 children and adolescents aged 5-20 years, referred to the Pediatric Nephrology, Dialysis and Transplant Unit of Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Milan, Italy were enrolled. Subjects with CKD stages II-V under conservative treatment (CKD-CT), or undergoing hemodialysis treatment (CKD-HD), or being renal transplant recipients (RTx) were included in the study. Data about age, primary renal disease and concomitant medications were collected for each subject.
CKD stages were defined using the K/DOQI criteria of the US National Kidney Foundation.
Control subjects were outpatients of the Pediatric Surgery Unit of the Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Milan, Italy, aged 1-20 years, who underwent a blood sample collection before a surgical intervention for the treatment of minor diseases that did not impair renal or endocrine function (i.e. phimosis, hydrocele, inguinal hernia).
Biochemical and hormonal parameters Blood samples were collected between 7:00 and 8:00 a.m. after an overnight fast, and before dialysis in CKD-HD patients. Routine biochemical parameters [creatinine, urea] were measured in all subjects. Glomerular filtration rate was estimated (eGFR) by the Schwartz formula, with k = 0.413, as appropriate for standardized creatinine.
In all subjects, plasma AG and UAG concentrations were measured by the Human Acylated / Unacylated Ghrelin ELISA kit (BioVendor, Laboratorni Medicina a.s., Brno, Czech Republic) according to manufacture procedures, and AG/UAG ratio was calculated. Serum obestatin concentrations were determined using the Human Obestatin ELISA kit (BioVendor, Laboratorni Medicina a.s., Brno, Czech Republic).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD-CT | – | Other: none interventionsubjects with CKD stages II-V under conservative treatment |
| CKD-HD | – | Other: none interventionsubjects with CKD stage V on hemodialysis |
| RTx renal transplant | – | Other: none interventionrenal transplant recipients |
| Controls | – | Other: none interventioncontrol subjects |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 154 subjects were included (M:F=100:54), 111 patients and 43 controls. Out of 111 patients, 43 had CKD stages II-V under conservative treatment (CKD-CT), 20 were on hemodialysis (CKD-HD), 48 were renal transplant recipients (RTx).
Key inclusion criteria (2 listed)
- the CKD-HD patients should have been on hemodialysis treatment for at least 3 months
- the RTx patients should have received renal transplantation at least 6 months before
Key exclusion criteria (3 listed)
- treatment with growth hormone
- the presence of neurologic disability or syndromic diseases affecting per se food intake
- for controls: they should have no history of chronic diseases and should not receive any medication. They should be on unrestricted diet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none interventionit is not an interventional study; it is an observational study | Other | CKD-CT, CKD-HD, Controls, RTx renal transplant |
Primary outcome
AG concentrations by ELISA kit on plasma samples
Time frame: January 2013-June 2015
Acyl-ghrelin measurement
UAG concentrations by ELISA kit on plasma samples
Time frame: January 2013-June 2015
Unacyl-ghrelin measurement
Obestatin concentrations by ELISA kit on serum samples
Time frame: January 2013-June 2015
Obestatin measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 21475675Mak RH, Ikizler AT, Kovesdy CP, Raj DS, Stenvinkel P, Kalantar-Zadeh K. Wasting in chronic kidney disease. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):9-25. doi: 10.1007/s13539-011-0019-5. Epub 2011 Mar 16.
- Background: PubMed 15187192Perez-Fontan M, Cordido F, Rodriguez-Carmona A, Peteiro J, Garcia-Naveiro R, Garcia-Buela J. Plasma ghrelin levels in patients undergoing haemodialysis and peritoneal dialysis. Nephrol Dial Transplant. 2004 Aug;19(8):2095-100. doi: 10.1093/ndt/gfh313. Epub 2004 Jun 8.
- Background: PubMed 16402931Iglesias P, Diez JJ, Fernandez-Reyes MJ, Codoceo R, Alvarez-Fidalgo P, Bajo MA, Aguilera A, Selgas R. Serum ghrelin concentrations in patients with chronic renal failure undergoing dialysis. Clin Endocrinol (Oxf). 2006 Jan;64(1):68-73. doi: 10.1111/j.1365-2265.2005.02418.x.
- Background: PubMed 17854954Barazzoni R, Zanetti M, Stulle M, Mucci MP, Pirulli A, Dore F, Panzetta G, Vasile A, Biolo G, Guarnieri G. Higher total ghrelin levels are associated with higher insulin-mediated glucose disposal in non-diabetic maintenance hemodialysis patients. Clin Nutr. 2008 Feb;27(1):142-9. doi: 10.1016/j.clnu.2007.06.013. Epub 2007 Sep 12.
- Background: PubMed 16198134Jarkovska Z, Hodkova M, Sazamova M, Rosicka M, Dusilova-Sulkova S, Marek J, Justova V, Lacinova Z, Haluzik M, Haas T, Krsek M. Plasma levels of active and total ghrelin in renal failure: a relationship with GH/IGF-I axis. Growth Horm IGF Res. 2005 Dec;15(6):369-76. doi: 10.1016/j.ghir.2005.07.004. Epub 2005 Sep 28.
- Background: PubMed 12397045Yoshimoto A, Mori K, Sugawara A, Mukoyama M, Yahata K, Suganami T, Takaya K, Hosoda H, Kojima M, Kangawa K, Nakao K. Plasma ghrelin and desacyl ghrelin concentrations in renal failure. J Am Soc Nephrol. 2002 Nov;13(11):2748-52. doi: 10.1097/01.asn.0000032420.12455.74.
- Background: PubMed 20018486Mafra D, Guebre-Egziabher F, Cleaud C, Arkouche W, Mialon A, Drai J, Fouque D. Obestatin and ghrelin interplay in hemodialysis patients. Nutrition. 2010 Nov-Dec;26(11-12):1100-4. doi: 10.1016/j.nut.2009.09.003. Epub 2009 Dec 16.
- Background: PubMed 20607302Buscher AK, Buscher R, Hauffa BP, Hoyer PF. Alterations in appetite-regulating hormones influence protein-energy wasting in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2010 Nov;25(11):2295-301. doi: 10.1007/s00467-010-1588-9. Epub 2010 Jul 6.
- Background: PubMed 15252183Nusken KD, Groschl M, Rauh M, Stohr W, Rascher W, Dotsch J. Effect of renal failure and dialysis on circulating ghrelin concentration in children. Nephrol Dial Transplant. 2004 Aug;19(8):2156-7. doi: 10.1093/ndt/gfh310. No abstract available.
- Background: PubMed 18809976Arbeiter AK, Buscher R, Petersenn S, Hauffa BP, Mann K, Hoyer PF. Ghrelin and other appetite-regulating hormones in paediatric patients with chronic renal failure during dialysis and following kidney transplantation. Nephrol Dial Transplant. 2009 Feb;24(2):643-6. doi: 10.1093/ndt/gfn529. Epub 2008 Sep 22.
- Derived from this study: PubMed 29150712Monzani A, Perrone M, Prodam F, Moia S, Genoni G, Testa S, Paglialonga F, Rapa A, Bona G, Montini G, Edefonti A. Unacylated ghrelin and obestatin: promising biomarkers of protein energy wasting in children with chronic kidney disease. Pediatr Nephrol. 2018 Apr;33(4):661-672. doi: 10.1007/s00467-017-3840-z. Epub 2017 Nov 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia Prodam, MD study director
Università del Piemonte Orientale - Novara
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Azienda Ospedaliero Universitaria Maggiore della Carita.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AG concentrations by ELISA kit on plasma samples (time frame: January 2013-June 2015). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171116, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.