Clinical TrialID 8010
Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
NCT05873322
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Drug-Induced Diabetes Mellitus|Impaired Glucose Tolerance|Lymphoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8010
- Evidence Id
- 8010
- Core Evidence Id
- 8010
- Source Clinical Trial Id
- 8005
- Herb2 Clinical Trial Id
- HBCT008005
- Nct Id
- NCT05873322
- Title
- Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma|Drug-Induced Diabetes Mellitus|Impaired Glucose Tolerance|Lymphoma
- Study Type
- Observational
- Study Design
- Observational Model: |Time Perspective: p
- Intervention
- Intervention Allocation
- Intervention Model
- Intervention Mask
- Intervention Purpose
- Gender
- All
- Age
- Child
- Enrollment
- 100
- Outcome Measure
- 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|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|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|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|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|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.|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.|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.|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.|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.|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|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.|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.|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.|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.|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.|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.|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.
- Sponsor Collaborator
- Aarhus University Hospital
- Funded By
- OTHER
- Location
- Aarhus University Hospital, Aarhus N, 8200, Denmark
- Other Id
- Glucose intolerance
- Start Date
- 2022-08-30
- Primary Completion Date
- 2025-12-31
- Completion Date
- 2025-12-31
- First Posted
- 2023-05-24
- Results First Posted
- Last Update Posted
- 2024-08-14
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05873322
- Title Cn
- Title En
- Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
- Bilingual Status
- semi_complete