NCT00801346已完成不适用
The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 3
- 主要终点
- Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose)
研究概览
简要总结
RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission.
详细描述
OBJECTIVES:
Primary
- To determine the incidence and prevalence of the components of metabolic syndrome (e.g., obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric patients with acute lymphoblastic leukemia in remission.
- To determine the trajectory of the onset of these components over a 1-year period in patients undergoing maintenance therapy.
Secondary
- To identify potential associations between components of metabolic syndrome and fatigue, health-related quality of life, family history, nutrition, and physical activity.
- To identify potential biomarkers that are associated with clinical features of metabolic syndrome.
- To evaluate whether patients will show a decrease in IGF-1 levels.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose)
次要结局
- Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months
- Family history as assessed by the Family History Questionnaire at baseline
- Health-related quality of life as assessed by the Pediatric Quality of Life Inventory and the Pediatric Quality of Life Cancer Module at baseline and at 6 and 12 months
- Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months
- Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months
- IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months
研究者
Adam Esbenshade
Assistant Professor
Vanderbilt University Medical Center
研究点 (3)
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