Diabetes Mellitus RiskDIAB-ONCONCT05525364
Hyperglycaemia In Childhood Hematologic Malignancies
An observational study of Diabetes Mellitus Risk, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
BACKGROUND/AIM: Secondary forms of diabetes are often understudied and underdiagnosed in children and adolescents with cancer. The objectives of this cohort study were to study the incidence and risk factors for hyperglycaemia in leukaemia and lymphoma patients. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Diabetes Mellitus Risk
- How many people
- 303 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2019to 31 Aug 2020
- Phase
- Observational
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Our cohort was composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL).
Who may be able to join
- Patients admitted to hemato-onco for acute lymphoblastic leukemia, Hodgkin's lymphoma or non-Hodgkin's lymphoma who are receiving treatments at diabetogenic risk for their cancer (i.e. glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial radiation)
- Age of the patient at presentation: 0 years - 18 years.
- For inclusion in the "hyperglycemia cohort":
- patients under diabetogenic treatment protocols such as glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial irradiation and hyperglycemia diagnosis according to the 2014 guidelines of the International Paediatric and Adolescent Diabetes Society (ISPAD).
Who cannot join
- patients with an incomplete file
- patients with history of the following conditions: previous diabetes (i.e., type 1, type 2, neonatal or monogenic diabetes), pancreatitis, steatosis, Down syndrome, pancreas and liver surgery, kidney disease and previous cancer other than leukaemia and lymphoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Hyperglycemia in a Cohort of Pediatric Patients Followed in Hemato-oncology for Cancer (DIAB-ONCO)
BACKGROUND/AIM: Secondary forms of diabetes are often understudied and underdiagnosed in children and adolescents with cancer. The objectives of this cohort study were to study the incidence and risk factors for hyperglycaemia in leukaemia and lymphoma patients.
METHODS: The investigators retrospectively collected 15 years of data from paediatric patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) immediately at cancer diagnosis. They studied risk factors for hyperglycaemia in univariate and multivariate analyses.
Read the detailed description
BACKGROUND:
Children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) are treated with specific and individual chemotherapy protocols sometimes combined with radiotherapy and/or hematopoietic stem cell transplant (HSCT). Thanks to research initiatives allowing constant re-evaluation of these protocols, survival rate of childhood cancer exceeds 83%. However, the effectiveness of these treatments is not without consequences: 50% of childhood cancer survivors (CCS) develop endocrine sequelae including metabolic syndrome and glucose metabolism disorders such as diabetes, insulin resistance and impaired glucose tolerance (IGT). In the general population, diabetes confers a 2 to 3 times increased risk of cardiovascular disease and corresponds to 12-55% of cases of end-stage renal disease worldwide, being as such the 7th expected leading cause of death by 2030.
In CCS, the incidence of hyperglycaemia is still ill-defined and might range between 11 and 35% of cases. Moreover, despite the whole body of evidence that asparaginase, steroids and total body irradiation increase the risk of developing hyperglycaemia and diabetes, risk factors are missing and - asides from treatments - understudied (e.g., pre-existing obesity, sex, age, ethnicity, family history of diabetes, etc.).
AIM:
DIAB-ONCO. The purpose of this study was to assess the incidence and associated risk factors of developing hyperglycaemia in children and adolescents diagnosed with ALL, HL and NHL. Deciphering the factors associated with the onset of hyperglycaemia in paediatric patients treated for cancer will provide leverage for lifestyle or therapeutic intervention from a prevention perspective in newly diagnosed patients.
INTERVENTION:
The DIABONCO retrospective study is being carried out in collaboration with the Paediatric Haematology and Oncology (Institut Roi Albert II) of Cliniques universitaires Saint-Luc in Belgium (Brussels). The local ethical committee (Saint-Luc and UCL Hospital-Faculty Ethics Committee) approved this study protocol (approval number 2018/20MAR/122) and the study was conducted in accordance with the Declaration of Helsinki.
This investigation included patients receiving treatment protocols conferring a diabetogenic risk. This included total body, cranial and abdominal irradiation (respectively TBI, CI and AI), steroids and L-asparaginase. Our cohort was therefore composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). The patients were stratified according to the presence or absence of hyperglycaemia during the treatment protocol and during clinical follow-up, which ended in August 2020. The groups were called the " hyperglycaemia-positive ALL, NHL or HL " and the "hyperglycaemia-free ALL, NHL or HL".
INCLUSION and EXCLUSION CRITERIA:
All children and adolescents aged 0 to 18 years treated with the aforementioned diabetogenic treatment protocols and diagnosed at Cliniques universitaires Saint-Luc with ALL, NHL or HL between January 2004 and December 2019 were included. Patients with an incomplete file or a history of the following conditions were excluded: previous diabetes (i.e., type 1, type 2, neonatal or monogenic diabetes), pancreatitis, steatosis, Down syndrome, pancreas and liver surgery, kidney disease and previous cancer other than leukaemia and lymphoma.
- Conditions
- Diabetes Mellitus Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Screening of diabetes | Our investigations included patients receiving treatment protocols conferring a diabetogenic risk. These included total body, cranial and abdominal irradiation (respectively TBI, CI and AI), steroids and L-asparaginase. Our cohort was therefore composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). The patients were stratified according to the presence or absence of hyperglycemia during the treatment protocol and during clinical follow-up, which ended in August 2020. The groups were called the "hyperglycaemia-positive ALL, NHL or HL" and the "hyperglycaemia-free ALL, NHL or HL". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables of interests - personal patient data and patient's family history
The investigators collected personal patient data such as sex, date of birth, country of origin, weight (kilograms), height (centimeters) and gestation at birth, complications during pregnancy (pre- or post-term, events, foetal macrosomia), dysmaturity, hypoglycaemia and hyperglycaemia in the neonatal period, the presence or absence of previous overweight (weight and height used to obtain BMI > 85th centile)/obesity (BMI > 95th centile), endocrine disease, autoimmune disease, acanthosis nigricans, sickle cell anaemia, any chronic treatment, date of death if patient died. Regarding the patient's family history, the investigators registered the presence or absence of previous gestational diabetes, polycystic ovarian syndrome, infertility, dystocia, consanguinity, diabetes, metabolic syndrome, sickle cell anaemia, pancreatic or liver surgery.
Measured: Through study completion, an average of two years
Variables of interests - Cancer and treatment data
The investigators also gathered information about the primary diagnosis and its treatment: type of cancer, diagnosis date, stage and localization of the tumour, anthropometric data on diagnosis (weight in kilograms, height in meters), tanner stage, blood pressure (systolic and diastolic), treatments protocols (presence or absence of steroids, asparaginase, radiotherapy and HSCT) and the presence of treatment side effects such as steroid-resistant disease, allergy to asparaginase, pancreatitis and steatosis induced by treatment protocol.
Measured: Through study completion, an average of two years
Variables of interests - Blood glucose and hyperglycemia data
When the patient developed hyperglycaemia more than twice, the date, the anthropometric data of onset (weight in kilograms, height in meters), the blood pressure, the treatment for the hyperglycaemia (e.g., insulin therapy, metformin), its doses per day, and its duration were reported. To obtain the number of blood glucose levels recorded, all blood glucose measurements from the start of treatment protocol until the end of our study were counted.
The duration of blood glucose monitoring was evaluated by counting blood glucose measurements performed without an interruption of more than six months and deceased patients were excluded. To evaluate the percentage of patients having been tested for blood glucose after the maintenance phase, the investigators included only ALL patients treated before 2015 and HL patients treated before 2017 to have a sufficient delay between the end of maintenance phase and the end of our study for the metabolic outcome monitoring.
Measured: Through study completion, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start20 Jun 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 303 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
- NCT05525364
- Sponsor's protocol ID
- DIAB-ONCO
- Acronym
- DIAB-ONCO
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Hyperglycemia in a Cohort of Pediatric Patients Followed in Hemato-oncology for Cancer (DIAB-ONCO)
- ClinicalTrials.gov ID
- NCT05525364
- Acronym / sponsor ID
- DIAB-ONCO / DIAB-ONCO
- Conditions
- Diabetes Mellitus Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 1 Sep 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/AIM: Secondary forms of diabetes are often understudied and underdiagnosed in children and adolescents with cancer. The objectives of this cohort study were to study the incidence and risk factors for hyperglycaemia in leukaemia and lymphoma patients.
METHODS: The investigators retrospectively collected 15 years of data from paediatric patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) immediately at cancer diagnosis. They studied risk factors for hyperglycaemia in univariate and multivariate analyses.
Detailed description
BACKGROUND:
Children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) are treated with specific and individual chemotherapy protocols sometimes combined with radiotherapy and/or hematopoietic stem cell transplant (HSCT). Thanks to research initiatives allowing constant re-evaluation of these protocols, survival rate of childhood cancer exceeds 83%. However, the effectiveness of these treatments is not without consequences: 50% of childhood cancer survivors (CCS) develop endocrine sequelae including metabolic syndrome and glucose metabolism disorders such as diabetes, insulin resistance and impaired glucose tolerance (IGT). In the general population, diabetes confers a 2 to 3 times increased risk of cardiovascular disease and corresponds to 12-55% of cases of end-stage renal disease worldwide, being as such the 7th expected leading cause of death by 2030.
In CCS, the incidence of hyperglycaemia is still ill-defined and might range between 11 and 35% of cases. Moreover, despite the whole body of evidence that asparaginase, steroids and total body irradiation increase the risk of developing hyperglycaemia and diabetes, risk factors are missing and - asides from treatments - understudied (e.g., pre-existing obesity, sex, age, ethnicity, family history of diabetes, etc.).
AIM:
DIAB-ONCO. The purpose of this study was to assess the incidence and associated risk factors of developing hyperglycaemia in children and adolescents diagnosed with ALL, HL and NHL. Deciphering the factors associated with the onset of hyperglycaemia in paediatric patients treated for cancer will provide leverage for lifestyle or therapeutic intervention from a prevention perspective in newly diagnosed patients.
INTERVENTION:
The DIABONCO retrospective study is being carried out in collaboration with the Paediatric Haematology and Oncology (Institut Roi Albert II) of Cliniques universitaires Saint-Luc in Belgium (Brussels). The local ethical committee (Saint-Luc and UCL Hospital-Faculty Ethics Committee) approved this study protocol (approval number 2018/20MAR/122) and the study was conducted in accordance with the Declaration of Helsinki.
This investigation included patients receiving treatment protocols conferring a diabetogenic risk. This included total body, cranial and abdominal irradiation (respectively TBI, CI and AI), steroids and L-asparaginase. Our cohort was therefore composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). The patients were stratified according to the presence or absence of hyperglycaemia during the treatment protocol and during clinical follow-up, which ended in August 2020. The groups were called the " hyperglycaemia-positive ALL, NHL or HL " and the "hyperglycaemia-free ALL, NHL or HL".
INCLUSION and EXCLUSION CRITERIA:
All children and adolescents aged 0 to 18 years treated with the aforementioned diabetogenic treatment protocols and diagnosed at Cliniques universitaires Saint-Luc with ALL, NHL or HL between January 2004 and December 2019 were included. Patients with an incomplete file or a history of the following conditions were excluded: previous diabetes (i.e., type 1, type 2, neonatal or monogenic diabetes), pancreatitis, steatosis, Down syndrome, pancreas and liver surgery, kidney disease and previous cancer other than leukaemia and lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening of diabetes | – | –Our investigations included patients receiving treatment protocols conferring a diabetogenic risk. These included total body, cranial and abdominal irradiation (respectively TBI, CI and AI), steroids and L-asparaginase. Our cohort was therefore composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). The patients were stratified according to the presence or absence of hyperglycemia during the treatment protocol and during clinical follow-up, which ended in August 2020. The groups were called the "hyperglycaemia-positive ALL, NHL or HL" and the "hyperglycaemia-free ALL, NHL or HL". |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Our cohort was composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL).
Key inclusion criteria (4 listed)
- Patients admitted to hemato-onco for acute lymphoblastic leukemia, Hodgkin's lymphoma or non-Hodgkin's lymphoma who are receiving treatments at diabetogenic risk for their cancer (i.e. glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial radiation)
- Age of the patient at presentation: 0 years - 18 years.
- patients under diabetogenic treatment protocols such as glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial irradiation and hyperglycemia diagnosis according to the 2014 guidelines of the International Paediatric and Adolescent Diabetes Society (ISPAD).
Key exclusion criteria (2 listed)
- patients with an incomplete file
- patients with history of the following conditions: previous diabetes (i.e., type 1, type 2, neonatal or monogenic diabetes), pancreatitis, steatosis, Down syndrome, pancreas and liver surgery, kidney disease and previous cancer other than leukaemia and lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variables of interests - personal patient data and patient's family history
Time frame: Through study completion, an average of two years
The investigators collected personal patient data such as sex, date of birth, country of origin, weight (kilograms), height (centimeters) and gestation at birth, complications during pregnancy (pre- or post-term, events, foetal macrosomia), dysmaturity, hypoglycaemia and hyperglycaemia in the neonatal period, the presence or absence of previous overweight (weight and height used to obtain BMI > 85th centile)/obesity (BMI > 95th centile), endocrine disease, autoimmune disease, acanthosis nigricans, sickle cell anaemia, any chronic treatment, date of death if patient died. Regarding the patient's family history, the investigators registered the presence or absence of previous gestational diabetes, polycystic ovarian syndrome, infertility, dystocia, consanguinity, diabetes, metabolic syndrome, sickle cell anaemia, pancreatic or liver surgery.
Variables of interests - Cancer and treatment data
Time frame: Through study completion, an average of two years
The investigators also gathered information about the primary diagnosis and its treatment: type of cancer, diagnosis date, stage and localization of the tumour, anthropometric data on diagnosis (weight in kilograms, height in meters), tanner stage, blood pressure (systolic and diastolic), treatments protocols (presence or absence of steroids, asparaginase, radiotherapy and HSCT) and the presence of treatment side effects such as steroid-resistant disease, allergy to asparaginase, pancreatitis and steatosis induced by treatment protocol.
Variables of interests - Blood glucose and hyperglycemia data
Time frame: Through study completion, an average of two years
When the patient developed hyperglycaemia more than twice, the date, the anthropometric data of onset (weight in kilograms, height in meters), the blood pressure, the treatment for the hyperglycaemia (e.g., insulin therapy, metformin), its doses per day, and its duration were reported. To obtain the number of blood glucose levels recorded, all blood glucose measurements from the start of treatment protocol until the end of our study were counted. The duration of blood glucose monitoring was evaluated by counting blood glucose measurements performed without an interruption of more than six months and deceased patients were excluded. To evaluate the percentage of patients having been tested for blood glucose after the maintenance phase, the investigators included only ALL patients treated before 2015 and HL patients treated before 2017 to have a sufficient delay between the end of maintenance phase and the end of our study for the metabolic outcome monitoring.
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 1 Sep 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 4 inclusion and 2 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 1 Sep 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?
Variables of interests - personal patient data and patient's family history (time frame: Through study completion, an average of two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2022.