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NCT05464043: DIAB-GRAFT
Hyperglycemia and (Pre)Diabetes in Pediatric Renal and Liver Transplantation.
NA trial testing evaluation of second line glucose homeostasis in Diabetes Mellitus Risk in 250 participants. Completed in 30 April 2022.
31 December 2019
Quick facts
| Lead sponsor | Université Catholique de Louvain |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 250 |
| Start date | 20 June 2019 |
| Primary completion | 31 December 2019 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- evaluation of second line glucose homeostasis
Conditions studied
- Diabetes Mellitus Risk — all drugs for Diabetes Mellitus Risk →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05464043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05464043 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Université Catholique de Louvain
- Last refreshed: 11 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05464043.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing