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

NCT05464043 | Completed

• 1 other identifier: DIAB-GRAFT
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Risk

Outcome Measures

Primary Outcomes (1)

• Retrospective study: characterization of hyperglycemia and diabetes after liver or kidney transplantation

  Incidence and risk factors of hyperglycemia and diabetes after liver or kidney transplantation

  Before transplantation until the end of the study (April 2022)

Secondary Outcomes (1)

• Prospective: analysis of impaired glucose tolerance (prediabetes) and diabetes after liver or kidney transplantation

  At day 14 post transplantation until 1 month for liver transplant and 9 months for kidney transplant

Study Arms (1)

diabetic cohort

EXPERIMENTAL

Patients who receive liver or kidney transplants and immunosuppressive drugs with diabetogenic risk. After 14 days of immunosuppressive therapy, all admitted patients will be evaluated for first-line glucose homeostasis. This patient cohort will be referred to as the "diabetes risk cohort". Subjects will then be stratified into two groups of patients: those who have developed glycemic dysregulation or diabetes during immunosuppressive therapy, the "diabetic cohort", and those who have not developed glycemic dysregulation or diabetes, the "control cohort". Only those who have developed glycemic dysregulation or diabetes during immunosuppressive therapy, i.e. the "diabetic cohort", will be analysed in more detail with the evaluation of second-line glucose homeostasis at three different times.

Diagnostic Test: evaluation of second line glucose homeostasis

Interventions

evaluation of second line glucose homeostasis DIAGNOSTIC_TEST

blood samples, urine samples, genetic test, peptide C stimulation test, OGTT, continuous glucose monitoring and questionnaires

diabetic cohort

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who have undergone liver and/or kidney transplantation and immunosuppressive treatments such as glucocorticoids, cyclosporin A, tacrolimus and sirolimus, treated and monitored in the gastroenterology and pediatric hepatology department and in the pediatric nephrology department (hospitalized patients and outpatient clinics) of Cliniques universitaires Saint-Luc.
• Informed consent obtained prior to any activity related to the trial. Test activities are all procedures performed as part of the test, including activities to determine test suitability.
• Age of the patient at presentation: 2 years - 18 years.

You may not qualify if:

• Diagnosis of type 1 or monogenic diabetes; Palliative care patients; History of pancreatitis (acute or chronic);

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc - UCLouvain

Brussels, 1200, Belgium

Location

Related Publications (1)

• Welsch S, Mailleux V, le Hardy de Beaulieu P, Ranguelov N, Godefroid N, Robert A, Stephenne X, Scheers I, Reding R, Sokal EM, Lysy PA. Characterization, evolution and risk factors of diabetes and prediabetes in a pediatric cohort of renal and liver transplant recipients. Front Pediatr. 2023 Feb 7;11:1080905. doi: 10.3389/fped.2023.1080905. eCollection 2023.

  PMID: 36824650 DERIVED

Study Officials

• Philippe Lysy, MD, Phd

  Cliniques Universitaires Saint-Luc UCLouvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: June 20, 2019
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)