Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ghrelin and Obestatin in CKD Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171116
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

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.


Condition or disease Intervention/treatment
Chronic Kidney Diseases Other: none intervention

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).


Layout table for study information
Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




Primary Outcome Measures :
  1. AG concentrations by ELISA kit on plasma samples [ Time Frame: January 2013-June 2015 ]
    Acyl-ghrelin measurement

  2. UAG concentrations by ELISA kit on plasma samples [ Time Frame: January 2013-June 2015 ]
    Unacyl-ghrelin measurement

  3. Obestatin concentrations by ELISA kit on serum samples [ Time Frame: January 2013-June 2015 ]
    Obestatin measurement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171116


Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Layout table for investigator information
Study Director: Flavia Prodam, MD Università del Piemonte Orientale - Novara

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Flavia Prodam, Clinical Professor, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03171116     History of Changes
Other Study ID Numbers: 396/2011 bis
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita:
ghrelin
obestatin
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency