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

Completed

• Conditions: Leukemia

• Registration Number: NCT00897078
• Lead Sponsor: Vanderbilt University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Meets one of the following eligibility criteria:

  • Childhood acute lymphoblastic leukemia survivor

    • Less than 22 years old at diagnosis

    • Treated from 1990-2007 at one of the following locations:

      • Fred Hutchinson Cancer Research Center and/or Children's Hospital and Regional Medical Center in Seattle, WA
      • Vanderbilt Children's Hospital in Nashville, TN

    • Meets 1 of the following treatment criteria:

      • Completed conventional therapy ≥ 11 months ago and in first complete remission
      • Received an allogeneic hematopoietic cell transplantation ≥ 11 months ago and in complete remission

    • No evidence of recurrent disease

  • Healthy volunteer

    • Full sibling of enrolled cancer survivor
    • Age 8-21 (if more than 1 eligible sibling, sibling of closest age is preferred)
    • No history of cancer

PATIENT CHARACTERISTICS:

• Able to speak, read, and write English

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No active treatment for graft-vs-host disease

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Exclusion Criteria

• Lack of ability to speak, read, and write English
• Active treatment for graft versus host disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Host- and treatment-related risk factors for MS	2009-2011
Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers	2009-2011

Trial Locations

Locations (2)

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States