NCT00897078

Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings

Health Effects After Leukemia (HEAL) Research Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease. PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.

Detailed description

OBJECTIVES: * Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e., obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood acute lymphoblastic leukemia and in healthy sibling volunteers. * Identify host- and treatment-related risk factors for MS. OUTLINE: This is a multicenter study. Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin. Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.

Conditions

• Leukemia

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	medical chart review
OTHER	metabolic assessment
OTHER	questionnaire administration	will be obtained at a single clinic visit
PROCEDURE	assessment of therapy complications

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-05-12
• Last updated: 2013-06-13

Locations

2 sites across 1 country: United States