Lymphoma Clinical Trial
Official title:
Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related impaired glucose tolerance | 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 | 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 | |
Primary | Number of participants with treatment-related diabetes | 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. | 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 | |
Primary | The extent of insulin resistance at baseline | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at baseline | |
Primary | The extent of insulin resistance at week 5 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 5 | |
Primary | The extent of insulin resistance at week 8 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 8 | |
Primary | The extent of insulin resistance at week 12/13 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 12/13. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of insulin resistance at week 15/16 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 15/16. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of insulin resistance at week 18/19 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 18/19. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of insulin resistance at week 20/21/22 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 20/21/22. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of insulin resistance at week 22/23/28 | Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 22/23/28. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of beta cell function at baseline | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at baseline | |
Primary | The extent of beta cell function at week 5 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 5. | |
Primary | The extent of beta cell function at week 8 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 8. | |
Primary | The extent of beta cell function at week 12/13 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 12/13. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of beta cell function at week 15/16 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 15/16. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of beta cell function at week 18/19 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 18/19. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of beta cell function at week 20/21/22 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 20/21/22. Which week depends on which risk group the patient belongs to. | |
Primary | The extent of beta cell function at week 22/23/28 | Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin | Fasting plasma glucose and insulin are measured at week 22/23/28. Which week depends on which risk group the patient belongs to. |
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