Ghrelin and Obestatin in CKD Children

May 28, 2017 updated by: Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

154

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

5 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CKD-CT
subjects with CKD stages II-V under conservative treatment
Other: none intervention
it is not an interventional study; it is an observational study
CKD-HD
subjects with CKD stage V on hemodialysis
Other: none intervention
it is not an interventional study; it is an observational study
RTx renal transplant
renal transplant recipients
Other: none intervention
it is not an interventional study; it is an observational study
Controls
control subjects
Other: none intervention
it is not an interventional study; it is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AG concentrations by ELISA kit on plasma samples
Time Frame: January 2013-June 2015
Acyl-ghrelin measurement
January 2013-June 2015
UAG concentrations by ELISA kit on plasma samples
Time Frame: January 2013-June 2015
Unacyl-ghrelin measurement
January 2013-June 2015
Obestatin concentrations by ELISA kit on serum samples
Time Frame: January 2013-June 2015
Obestatin measurement
January 2013-June 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Study Director: Flavia Prodam, MD, Università del Piemonte Orientale - Novara

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.

General Publications

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 (Actual)

January 1, 2013

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 28, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 28, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 396/2011 bis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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