Clinical trial · Observational
Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall survival of acute lymphoblastic leukemia (ALL) and lymphoma in children and adolescents is above 90%. The survival rate has increased significantly during the last decades as a consequence of more intensive chemotherapy. This very toxic treatment results in severe acute toxicities and late effects, which is the biggest challenge today besides survival. The overall purpose of contemporary ALL treatment is to reduce the toxic treatment without compromising the excellent survival rates of these diseases. This study is a part of this. The researchers want to investigate the incidence of glucose intolerance and medicine induced diabetes during treatment for ALL and lymphoma with steroids (prednisolone or dexamethasone) and ± PEG-asparaginase. Steroids and asparaginase are used in the treatment of ALL and lymphomas, and both drugs may induce glucose intolerance or diabetes, especially when they are given concomitantly. The incidence and duration of increased blood glucose levels are not very well investigated, and especially not monitored continuously during treatment phases with steroids and +/- asparaginase, as the investigators want to do in this study. In the study the participants must have a glucose sensor attached under the skin, which continuously measures blood glucose during treatment. Moreover, blood samples are drawn several times to measure insulin sensitivity and beta cell function. The participants are children and adolescents (1.0-17.9 years) with newly diagnosed ALL or lymphoma treated at one of the four Danish pediatric oncology sites. Blood glucose levels are followed during treatment with steroids and PEG-asparaginase in these patient groups. The results may give rise to a new treatment guidelines for measuring and treating blood glucose in these patients. In the future this may help reduce the development of type 2 diabetes mellitus and metabolic syndrome in survivors of ALL and lymphoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug-Induced Diabetes Mellitus | — | UNRESOLVED | — |
| Impaired Glucose Tolerance | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (18)
- measure
- Number of participants with treatment-related impaired glucose tolerance
- timeFrame
- CGM is used from the beginning of ALL/lymphoma treatment day 1 and in up to 120 days. For the ALL patient in the induction phase, consolidation 2 and delayed intensification phase
- description
- Glucose levels are measured using the technology continuous glucose monitoring (CGM). A glucose sensor is attached under the skin which continuously measures the glucose level every 5 minutes during treatment with steroids or PEG-Asparaginase. Impaired glucose tolerance is defined as a blood glucose (BG) 2 hours after a meal between 7.8-11 mmol/l
- measure
- Number of participants with treatment-related diabetes
- timeFrame
- CGM is used from the beginning of ALL/lymphoma treatment day 1 and in up to 120 days. For the ALL patient in the induction phase, consolidation 2 and delayed intensification phase
- description
- Glucose levels are measured using the technology continuous glucose monitoring (CGM). A glucose sensor is attached under the skin which continuously measures the glucose level every 5 minutes during treatment with steroids or PEG-Asparaginase. Diabetes is defined as a fasting BG ≥7 mmol/l or BG after a meal ≥ 11.1 mmol/l.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * All children and adolescents diagnosed with ALL and Lymphoma and treated according to the established and approved treatment protocols for these diseases in Denmark can be included in the study. Exclusion Criteria: * Children and adolescents not fulfilling the inclusion criteria.
References
Publications (0)
Data not yet available