Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The extent of beta cell function at week 22/23/28
研究概览
简要总结
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.
详细描述
Purpose:
Survival rates for acute lymphoblastic leukemia (ALL) have improved during the last decades. Accordingly, the research now also focuses more on reducing the acute toxicities during treatment and the risk of late effects after treatment without compromising overall survival.
Main aim:
To investigate the incidence and severity of medication induced glucose intolerance and diabetes mellitus in children and adolescents (1.0-17.9) treated for acute lymphoblastic leukemia or lymphoma.
Secondary aim:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Children and adolescents not fulfilling the inclusion criteria.
结局指标
主要结局
The extent of beta cell function at week 22/23/28
时间窗: Fasting plasma glucose and insulin are measured at week 22/23/28. Which week depends on which risk group the patient belongs to.
Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin
The extent of beta cell function at week 5
时间窗: Fasting plasma glucose and insulin are measured 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
The extent of insulin resistance at baseline
时间窗: Fasting plasma glucose and insulin are measured at baseline
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 20/21/22
时间窗: Fasting plasma glucose and insulin are measured at week 20/21/22. Which week depends on which risk group the patient belongs to.
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 22/23/28
时间窗: Fasting plasma glucose and insulin are measured at week 22/23/28. Which week depends on which risk group the patient belongs to.
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 12/13
时间窗: Fasting plasma glucose and insulin are measured at week 12/13. Which week depends on which risk group the patient belongs to.
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 15/16
时间窗: Fasting plasma glucose and insulin are measured at week 15/16. Which week depends on which risk group the patient belongs to.
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of beta cell function at week 8
时间窗: Fasting plasma glucose and insulin are measured 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
The extent of beta cell function at week 15/16
时间窗: Fasting plasma glucose and insulin are measured at week 15/16. Which week depends on which risk group the patient belongs to.
Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin
Number of participants with treatment-related impaired glucose tolerance
时间窗: 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
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
Number of participants with treatment-related diabetes
时间窗: 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
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.
The extent of beta cell function at baseline
时间窗: Fasting plasma glucose and insulin are measured at baseline
Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 5
时间窗: Fasting plasma glucose and insulin are measured at week 5
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 8
时间窗: Fasting plasma glucose and insulin are measured at week 8
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of insulin resistance at week 18/19
时间窗: Fasting plasma glucose and insulin are measured at week 18/19. Which week depends on which risk group the patient belongs to.
Insulin resistance is calculated from the homeostasis model assessment of insulin resistance using fasting plasma glucose and fasting plasma insulin
The extent of beta cell function at week 20/21/22
时间窗: Fasting plasma glucose and insulin are measured at week 20/21/22. Which week depends on which risk group the patient belongs to.
Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin
The extent of beta cell function at week 12/13
时间窗: Fasting plasma glucose and insulin are measured at week 12/13. Which week depends on which risk group the patient belongs to.
Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin
The extent of beta cell function at week 18/19
时间窗: Fasting plasma glucose and insulin are measured at week 18/19. Which week depends on which risk group the patient belongs to.
Beta cell function is calculated from the homeostasis model assessment of beta cell function using fasting plasma glucose and fasting plasma insulin
次要结局
未报告次要终点
研究者
Birgitte Klug Albertsen
MD, PhD, Associate Professor
Aarhus University Hospital