Ghrelin and Obestatin in CKD Children (NCT03171116) | Clinical Trial Compass
CompletedNot Applicable
Ghrelin and Obestatin in CKD Children
154 participantsStarted 2013-01-01
Plain-language 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.
Who can participate
Age range
5 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AG concentrations by ELISA kit on plasma samples
Timeframe: January 2013-June 2015
2
UAG concentrations by ELISA kit on plasma samples
Timeframe: January 2013-June 2015
3
Obestatin concentrations by ELISA kit on serum samples
Timeframe: January 2013-June 2015
Trial details
NCT IDNCT03171116
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita