Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings
|ClinicalTrials.gov Identifier: NCT00897078|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : June 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Other: laboratory biomarker analysis Other: medical chart review Other: metabolic assessment Other: questionnaire administration Procedure: assessment of therapy complications||Phase 1|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Health Effects After Leukemia (HEAL) Research Study|
|Study Start Date :||January 2009|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
Other: laboratory biomarker analysis
- Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers [ Time Frame: 2009-2011 ]
- Host- and treatment-related risk factors for MS [ Time Frame: 2009-2011 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897078
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Jill Simmons, MD||Vanderbilt-Ingram Cancer Center|