Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

• 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) [ Designated as safety issue: No ]
  

• Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  
• Family history as assessed by the Family History Questionnaire at baseline [ Designated as safety issue: No ]
  
• 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 [ Designated as safety issue: No ]
  
• Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  
• Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  
• IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months [ Designated as safety issue: No ]
  

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.

OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.

• Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist circumference, and blood pressure) at baseline (during maintenance course 1) and at 12 months (during maintenance course 5). Patients also undergo blood sample collection at baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile, fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their parents complete a family history questionnaire at baseline and questionnaires to assess physical activity, quality of life, nutritional intake, and fatigue at baseline and at 6 and 12 months.
• Part 2: Patients or their parents complete a family history questionnaire at baseline.