Screening for Hyperglycemia in a Cohort of Pediatric Patients Followed in Hemato-oncology for Cancer (DIAB-ONCO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Variables of interests - personal patient data and patient's family history
研究概览
简要总结
BACKGROUND/AIM: Secondary forms of diabetes are often understudied and underdiagnosed in children and adolescents with cancer. The objectives of this cohort study were to study the incidence and risk factors for hyperglycaemia in leukaemia and lymphoma patients.
METHODS: The investigators retrospectively collected 15 years of data from paediatric patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) immediately at cancer diagnosis. They studied risk factors for hyperglycaemia in univariate and multivariate analyses.
详细描述
BACKGROUND:
Children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) are treated with specific and individual chemotherapy protocols sometimes combined with radiotherapy and/or hematopoietic stem cell transplant (HSCT). Thanks to research initiatives allowing constant re-evaluation of these protocols, survival rate of childhood cancer exceeds 83%. However, the effectiveness of these treatments is not without consequences: 50% of childhood cancer survivors (CCS) develop endocrine sequelae including metabolic syndrome and glucose metabolism disorders such as diabetes, insulin resistance and impaired glucose tolerance (IGT). In the general population, diabetes confers a 2 to 3 times increased risk of cardiovascular disease and corresponds to 12-55% of cases of end-stage renal disease worldwide, being as such the 7th expected leading cause of death by 2030.
In CCS, the incidence of hyperglycaemia is still ill-defined and might range between 11 and 35% of cases. Moreover, despite the whole body of evidence that asparaginase, steroids and total body irradiation increase the risk of developing hyperglycaemia and diabetes, risk factors are missing and - asides from treatments - understudied (e.g., pre-existing obesity, sex, age, ethnicity, family history of diabetes, etc.).
AIM:
DIAB-ONCO. The purpose of this study was to assess the incidence and associated risk factors of developing hyperglycaemia in children and adolescents diagnosed with ALL, HL and NHL. Deciphering the factors associated with the onset of hyperglycaemia in paediatric patients treated for cancer will provide leverage for lifestyle or therapeutic intervention from a prevention perspective in newly diagnosed patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to hemato-onco for acute lymphoblastic leukemia, Hodgkin's lymphoma or non-Hodgkin's lymphoma who are receiving treatments at diabetogenic risk for their cancer (i.e. glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial radiation)
- •Age of the patient at presentation: 0 years - 18 years.
- •For inclusion in the "hyperglycemia cohort":
- •patients under diabetogenic treatment protocols such as glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial irradiation and hyperglycemia diagnosis according to the 2014 guidelines of the International Paediatric and Adolescent Diabetes Society (ISPAD).
排除标准
- •patients with an incomplete file
- •patients with history of the following conditions: previous diabetes (i.e., type 1, type 2, neonatal or monogenic diabetes), pancreatitis, steatosis, Down syndrome, pancreas and liver surgery, kidney disease and previous cancer other than leukaemia and lymphoma.
结局指标
主要结局
Variables of interests - personal patient data and patient's family history
时间窗: Through study completion, an average of two years
The investigators collected personal patient data such as sex, date of birth, country of origin, weight (kilograms), height (centimeters) and gestation at birth, complications during pregnancy (pre- or post-term, events, foetal macrosomia), dysmaturity, hypoglycaemia and hyperglycaemia in the neonatal period, the presence or absence of previous overweight (weight and height used to obtain BMI \> 85th centile)/obesity (BMI \> 95th centile), endocrine disease, autoimmune disease, acanthosis nigricans, sickle cell anaemia, any chronic treatment, date of death if patient died. Regarding the patient's family history, the investigators registered the presence or absence of previous gestational diabetes, polycystic ovarian syndrome, infertility, dystocia, consanguinity, diabetes, metabolic syndrome, sickle cell anaemia, pancreatic or liver surgery.
Variables of interests - Cancer and treatment data
时间窗: Through study completion, an average of two years
The investigators also gathered information about the primary diagnosis and its treatment: type of cancer, diagnosis date, stage and localization of the tumour, anthropometric data on diagnosis (weight in kilograms, height in meters), tanner stage, blood pressure (systolic and diastolic), treatments protocols (presence or absence of steroids, asparaginase, radiotherapy and HSCT) and the presence of treatment side effects such as steroid-resistant disease, allergy to asparaginase, pancreatitis and steatosis induced by treatment protocol.
Variables of interests - Blood glucose and hyperglycemia data
时间窗: Through study completion, an average of two years
When the patient developed hyperglycaemia more than twice, the date, the anthropometric data of onset (weight in kilograms, height in meters), the blood pressure, the treatment for the hyperglycaemia (e.g., insulin therapy, metformin), its doses per day, and its duration were reported. To obtain the number of blood glucose levels recorded, all blood glucose measurements from the start of treatment protocol until the end of our study were counted. The duration of blood glucose monitoring was evaluated by counting blood glucose measurements performed without an interruption of more than six months and deceased patients were excluded. To evaluate the percentage of patients having been tested for blood glucose after the maintenance phase, the investigators included only ALL patients treated before 2015 and HL patients treated before 2017 to have a sufficient delay between the end of maintenance phase and the end of our study for the metabolic outcome monitoring.
次要结局
未报告次要终点