Actively Recruiting
Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG-Asparaginase in Children and Adolescents With ALL and Lymphoma
Led by Aarhus University Hospital · Updated on 2024-08-14
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children and adolescents aged 1 to 17.9 years with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoma to understand how treatment with steroids (prednisolone or dexamethasone) and possibly PEG-asparaginase affects blood sugar levels. While survival rates for these diseases are above 90%, the treatments can cause severe side effects including glucose intolerance and diabetes, which this study aims to monitor more closely. Participants will wear a glucose sensor under the skin to continuously measure blood sugar during treatment phases involving steroids and PEG-asparaginase. Blood samples will also be taken several times to assess insulin sensitivity and pancreatic function. The study will observe blood sugar changes during key treatment periods, including induction, consolidation, and delayed intensification phases, to better understand medication-induced diabetes and glucose intolerance. Throughout the study, participants will have regular visits for sensor replacement and blood tests aligned with their treatment schedule. Researchers will analyze continuous glucose monitoring data and blood test results to track blood sugar levels, insulin resistance, and beta cell function over time. The findings may help develop new guidelines for monitoring and managing blood sugar during treatment, potentially reducing long-term risks like type 2 diabetes and metabolic syndrome in survivors.
CONDITIONS
Brief Title
Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) and lymphoma
- Treated according to established and approved treatment protocols for these diseases in Denmark
- Age between 1.0 and 17.9 years
You will not qualify if you...
- Children and adolescents not meeting the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 120 days during treatment phases including induction, consolidation, and delayed intensification
Participants have a glucose sensor attached under the skin to continuously measure blood glucose levels during treatment with steroids and PEG-Asparaginase. Blood samples are drawn several times to measure insulin sensitivity and beta cell function before, during, and after treatment.
Regular visits for sensor renewal and blood tests in parallel with hospital treatment visits
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
B
Birgitte K Albertsen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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