Diabetes Mellitus RiskDIAB-GRAFTNCT05464043
Hyperglycemia and (Pre)Diabetes in Pediatric Renal and Liver Transplantation.
A study testing evaluation of second line glucose homeostasis in people with Diabetes Mellitus Risk, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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)… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Diabetes Mellitus Risk
- What is being tested?
- evaluation of second line glucose homeostasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- For inclusion in the diabetogenic risk cohort: patients under diabetogenic treatment protocols such as glucocorticoids, cyclosporin A and tacrolimus.
- For inclusion in the diabetic cohort: patients under diabetogenic treatment protocols such as glucocorticoids, cyclosporin A and tacrolimus and diabetes diagnosis according to the 2014 guidelines of the International Paediatric and Adolescent Diabetes Society (ISPAD).
Who cannot join
- Diagnosis of type 1 or monogenic diabetes; Palliative care patients; History of pancreatitis (acute or chronic);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Diabetes and Pre-diabetes in a Cohort of Pediatric Patients Who Have Received a Liver or Kidney Transplant (DIAB-GRAFT)
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.
Read the detailed description
BACKGROUND/AIM: Solid organ transplantation (SOT) is therapeutic choice for patient in end-stage renal or liver disease. After transplant, immunosuppressive therapy is necessary to avoid rejection and their use has enabled SOT and considerably improved graft survival and quality of life. However, they are also associated with side effects, including glycemic abnormalities. Most complications observed with immunosuppressants are the presence of hyperglycemia which in the long term may increase the probabilities to develop persistent diabetes. Diabetes affects an ill-defined proportion of transplanted patients (2 to 53%) and in the context of adult liver and renal transplant, it is nonetheless common, and represents approximately 20%. However, the incidence of transient hyperglycemia and the probabilities to develop overt diabetes in pediatric liver and renal transplantation remains unknow, while it is known that both is associated with an unfavorable prognosis (i.e., mortality, graft rejection, increased hospital stay) and an increased cardiovascular event in the long term. Moreover, associated risk factors such as obesity, metabolic syndrome, sedentary lifestyle, or even older age are well known for adult transplant but do not make sense for children transplanted at a very young age. In addition, the use of a non-relevant measure such as fasting blood glucose and a late-onset diabetes marker like HbA1C levels do not allow the early detection of impaired glucose tolerance (IGT) a signal alarm of a prediabetes state. Prediabetes is considered as an intermediate state between normal glucose homeostasis and overt diabetes and represents a major health problem because it is estimated in 2015 that 70% of the prediabetic American citizens (33,5%) will develop diabetes in the period. However, it is rarely sought in pediatric transplantation while the early detection and correction of hyperglycemia was shown to significantly decrease both cardiovascular and diabetes risk. It is therefore essential to develop knowledge on the evolution of glucose dysregulation after a renal and liver transplantation with the implementation of other markers of hyperglycemia or IGT. Then the purpose of the DIABGRAFT study was to assess the incidence and associated risk factors of developing hyperglycemia in renal and liver transplanted children to anticipate it and analyze their glycemic profile during the most critical moment to characterize hyperglycemia, IGT and diabetes.
METHODS: In collaboration with the Pediatric Gastroenterology and Specialized Pediatrics Services (Endocrinology and Nephrology Units) of Cliniques universitaires Saint Luc (CUSL) in Belgium (Brussels), this clinical study will be organized as a retrospective and a prospective trial.
The study included liver and renal transplanted pediatric patients (<18 years of age) at CUSL. Were excluded patients with a history of diabetes (i.e., type 1, type 2, neonatal or monogenic), pancreatitis, Down Syndrome, cystic fibrosis, another transplantation (cardiac, renal) only for liver transplanted patients, patients deceased shortly after transplantation, and patients with incomplete medical record.
Its retrospective part (rDIABGRAFT) consisted of collecting data of pediatric patients who benefited from a liver transplant performed at CUSL between April 2012 and April 2019, or that benefited from a renal transplant in our center between April 2005 and April 2019.
The prospective part (pDIABGRAFT) of the study consisted of a longitudinal glycemic evaluation of renal and liver transplanted children in CUSL between 2020 and 2022 with the use of dynamic endocrine testing. Informed consents were collected from parents and from all children over six years of age.
- Conditions
- Diabetes Mellitus Risk
- Being tested
- evaluation of second line glucose homeostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of second line glucose homeostasisDiagnostic test
blood samples, urine samples, genetic test, peptide C stimulation test, OGTT, continuous glucose monitoring and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: evaluation of second line glucose homeostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Composite of tests and analysis to evaluate glucose homeostasis
Measured: At day 14 post transplantation until 1 month for liver transplant and 9 months for kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start20 Jun 2019
- Primary completion31 Dec 2019
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus RiskStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lysy, MD, Phd, Principal investigator, Cliniques Universitaires Saint-Luc UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464043
- Sponsor's protocol ID
- DIAB-GRAFT
- Acronym
- DIAB-GRAFT
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36824650
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Diabetes and Pre-diabetes in a Cohort of Pediatric Patients Who Have Received a Liver or Kidney Transplant (DIAB-GRAFT)
- ClinicalTrials.gov ID
- NCT05464043
- Acronym / sponsor ID
- DIAB-GRAFT / DIAB-GRAFT
- Conditions
- Diabetes Mellitus Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND/AIM: Solid organ transplantation (SOT) is therapeutic choice for patient in end-stage renal or liver disease. After transplant, immunosuppressive therapy is necessary to avoid rejection and their use has enabled SOT and considerably improved graft survival and quality of life. However, they are also associated with side effects, including glycemic abnormalities. Most complications observed with immunosuppressants are the presence of hyperglycemia which in the long term may increase the probabilities to develop persistent diabetes. Diabetes affects an ill-defined proportion of transplanted patients (2 to 53%) and in the context of adult liver and renal transplant, it is nonetheless common, and represents approximately 20%. However, the incidence of transient hyperglycemia and the probabilities to develop overt diabetes in pediatric liver and renal transplantation remains unknow, while it is known that both is associated with an unfavorable prognosis (i.e., mortality, graft rejection, increased hospital stay) and an increased cardiovascular event in the long term. Moreover, associated risk factors such as obesity, metabolic syndrome, sedentary lifestyle, or even older age are well known for adult transplant but do not make sense for children transplanted at a very young age. In addition, the use of a non-relevant measure such as fasting blood glucose and a late-onset diabetes marker like HbA1C levels do not allow the early detection of impaired glucose tolerance (IGT) a signal alarm of a prediabetes state. Prediabetes is considered as an intermediate state between normal glucose homeostasis and overt diabetes and represents a major health problem because it is estimated in 2015 that 70% of the prediabetic American citizens (33,5%) will develop diabetes in the period. However, it is rarely sought in pediatric transplantation while the early detection and correction of hyperglycemia was shown to significantly decrease both cardiovascular and diabetes risk. It is therefore essential to develop knowledge on the evolution of glucose dysregulation after a renal and liver transplantation with the implementation of other markers of hyperglycemia or IGT. Then the purpose of the DIABGRAFT study was to assess the incidence and associated risk factors of developing hyperglycemia in renal and liver transplanted children to anticipate it and analyze their glycemic profile during the most critical moment to characterize hyperglycemia, IGT and diabetes.
METHODS: In collaboration with the Pediatric Gastroenterology and Specialized Pediatrics Services (Endocrinology and Nephrology Units) of Cliniques universitaires Saint Luc (CUSL) in Belgium (Brussels), this clinical study will be organized as a retrospective and a prospective trial.
The study included liver and renal transplanted pediatric patients (<18 years of age) at CUSL. Were excluded patients with a history of diabetes (i.e., type 1, type 2, neonatal or monogenic), pancreatitis, Down Syndrome, cystic fibrosis, another transplantation (cardiac, renal) only for liver transplanted patients, patients deceased shortly after transplantation, and patients with incomplete medical record.
Its retrospective part (rDIABGRAFT) consisted of collecting data of pediatric patients who benefited from a liver transplant performed at CUSL between April 2012 and April 2019, or that benefited from a renal transplant in our center between April 2005 and April 2019.
The prospective part (pDIABGRAFT) of the study consisted of a longitudinal glycemic evaluation of renal and liver transplanted children in CUSL between 2020 and 2022 with the use of dynamic endocrine testing. Informed consents were collected from parents and from all children over six years of age.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic cohort | Experimental | Diagnostic Test: evaluation of second line glucose homeostasisPatients 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- For inclusion in the diabetogenic risk cohort: patients under diabetogenic treatment protocols such as glucocorticoids, cyclosporin A and tacrolimus.
- For inclusion in the diabetic cohort: patients under diabetogenic treatment protocols such as glucocorticoids, cyclosporin A and tacrolimus and diabetes diagnosis according to the 2014 guidelines of the International Paediatric and Adolescent Diabetes Society (ISPAD).
Key exclusion criteria (1 listed)
- Diagnosis of type 1 or monogenic diabetes; Palliative care patients; History of pancreatitis (acute or chronic);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of second line glucose homeostasisblood samples, urine samples, genetic test, peptide C stimulation test, OGTT, continuous glucose monitoring and questionnaires | Diagnostic test | diabetic cohort |
Primary outcome
Retrospective study: characterization of hyperglycemia and diabetes after liver or kidney transplantation
Time frame: Before transplantation until the end of the study (April 2022)
Incidence and risk factors of hyperglycemia and diabetes after liver or kidney transplantation
1 secondary outcome
Prospective: analysis of impaired glucose tolerance (prediabetes) and diabetes after liver or kidney transplantation
Time frame: At day 14 post transplantation until 1 month for liver transplant and 9 months for kidney transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Derived from this study: PubMed 36824650Welsch 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus Risk
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Lysy, MD, Phd principal investigator
Cliniques Universitaires Saint-Luc UCLouvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of second line glucose homeostasis in people with Diabetes Mellitus Risk, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study: characterization of hyperglycemia and diabetes after liver or kidney transplantation (time frame: Before transplantation until the end of the study (April 2022)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.