Ghrelin and Obestatin in CKD Children

NCT03171116 | Completed

• 1 other identifier: 396/2011 bis
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Kidney Diseases

Keywords

ghrelin; obestatin; children

Outcome Measures

Primary Outcomes (3)

• AG concentrations by ELISA kit on plasma samples

  Acyl-ghrelin measurement

  January 2013-June 2015

• UAG concentrations by ELISA kit on plasma samples

  Unacyl-ghrelin measurement

  January 2013-June 2015

• Obestatin concentrations by ELISA kit on serum samples

  Obestatin measurement

  January 2013-June 2015

Study Arms (4)

CKD-CT

subjects with CKD stages II-V under conservative treatment

Other: none intervention

CKD-HD

subjects with CKD stage V on hemodialysis

Other: none intervention

RTx renal transplant

renal transplant recipients

Other: none intervention

Controls

control subjects

Other: none intervention

Interventions

none intervention OTHER

it is not an interventional study; it is an observational study

CKD-CT; CKD-HD; Controls; RTx renal transplant

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Related Publications (11)

• 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.

  PMID: 21475675 BACKGROUND

• Perez-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.

  PMID: 15187192 BACKGROUND

• Iglesias 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.

  PMID: 16402931 BACKGROUND

• Barazzoni 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.

  PMID: 17854954 BACKGROUND

• Jarkovska 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.

  PMID: 16198134 BACKGROUND

• Yoshimoto 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.

  PMID: 12397045 BACKGROUND

• Mafra 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.

  PMID: 20018486 BACKGROUND

• Buscher 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.

  PMID: 20607302 BACKGROUND

• Nusken 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.

  PMID: 15252183 BACKGROUND

• Arbeiter 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.

  PMID: 18809976 BACKGROUND

• Monzani 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.

  PMID: 29150712 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Flavia Prodam, MD

  Università del Piemonte Orientale - Novara

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: January 1, 2013
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share