Ghrelin and Obestatin in CKD Children

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.

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Key information

Conditions

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

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

None intervention

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Official study title

Unacylated Ghrelin and Obestatin as Promising Biomarkers of Protein Energy Wasting in Children With Chronic Kidney Disease: a Cross-sectional Case-control Study

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: May 31, 2017
Registry last updated: May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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