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

NCT05873322 | Recruiting

• 1 other identifier: Glucose intolerance
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Drug-Induced Diabetes Mellitus; Impaired Glucose Tolerance; Lymphoma

Outcome Measures

Primary Outcomes (18)

• 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.

Eligibility Criteria

• Age: 1 Year - 17 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children and adolescents (1.0-17.9 years) with newly diagnosed ALL or lymphoma and treated in Denmark

You may qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Glucose Intolerance; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Birgitte K Albertsen

CONTACT

004520224643; biralber@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: May 24, 2023
• Study Start: August 30, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

DK (1)