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NCT05464043: DIAB-GRAFT

Hyperglycemia and (Pre)Diabetes in Pediatric Renal and Liver Transplantation.

Completed NA Last updated 11 August 2022
What this trial tests

NA trial testing evaluation of second line glucose homeostasis in Diabetes Mellitus Risk in 250 participants. Completed in 30 April 2022.

Timeline
20 June 2019
Primary endpoint
31 December 2019
30 April 2022

Quick facts

Lead sponsorUniversité Catholique de Louvain
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment250
Start date20 June 2019
Primary completion31 December 2019
Estimated completion30 April 2022
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Université Catholique de Louvain — full company profile →

Who can join

Adults 2 to 18, any sex, with Diabetes Mellitus Risk. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Diabetes is a common complication of transplantation and is associated with unfavorable medical outcome and increased cardiovascular disease at long term. However, prediabetes defined by an impaired glucose tolerance and/or impaired fasting glucose is rarely sought in pediatric liver (LT) and renal (RT) transplantation, while its presence indicates a high risk of overt diabetes and complications thereof. Early detection of hyperglycemia might mitigate those risks. The objectives of the DIABGRAFT study were to retrospectively (rDIABGRAFT) and longitudinally (pDIABGRAFT) characterize hyperglycemia and (pre)diabetes in a cohort of children with RT or/and LT. Methods: The investigators retrospectively collected data about 195 children with LT from 2012 and 2019 and twenty children with RT from 2005 to 2019 in Cliniques universitaires Saint Luc to determine the incidence, risk factors and time at onset of chronic hyperglycemia. In addition, the investigators prospectively followed four LT and four RT children between 2019 and 2022 to evaluate the evolution of their glucose metabolism.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Characterization, evolution and risk factors of diabetes and prediabetes in a pediatric cohort of renal and liver transplant recipients.
    Welsch S, Mailleux V, le Hardy de Beaulieu P, Ranguelov N, et al · · 2023 · PMID 36824650 · DOI 10.3389/fped.2023.1080905

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Other recruiting trials for Diabetes Mellitus Risk

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