NCT00801346

Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 224 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fatigue
• Leukemia
• Long-term Effects Secondary to Cancer Therapy in Children

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	metabolic assessment
OTHER	questionnaire administration
PROCEDURE	assessment of therapy complications
PROCEDURE	fatigue assessment and management
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2008-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2008-12-03
• Last updated: 2017-04-21

Locations

3 sites across 1 country: United States