Actively Recruiting

Age: 1Year - 17Years
All Genders
NCT05873322

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

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 1.0 to 17.9 years diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma
  • Treated according to the approved treatment protocols for ALL and lymphoma in Denmark
Not Eligible

You will not qualify if you...

  • Children and adolescents not meeting the inclusion criteria

AI-Screening

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Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus N, Denmark, 8200

Actively Recruiting

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Research Team

B

Birgitte K Albertsen

CONTACT

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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