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Completed

NCT Number: NCT00920738

Metabolic Syndrome in Childhood Cancer Survivors

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Chronic Disease Cranial Nerve Diseases Cranial Nerve Neoplasms Disease Attributes Eye Diseases Familial ependymoma Glioma Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hyperinsulinism Immune System Diseases Immunoproliferative Disorders Insulin Resistance Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Metabolic Diseases Metabolic Syndrome Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Nutritional and Metabolic Diseases Oligodendroglioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Sarcoma

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

About this study

OBJECTIVES:

Primary

  • Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
  • Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
  • Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
  • Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines [adiponectin, leptin], inflammatory mediators [e.g., interleukin-6], tumor necrosis factor-α, and C-reactive protein).
  • Obtain dietary and physical activity assessments of CCS and healthy siblings.

Secondary

  • Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.

OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.

Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
  • Subjects will be 9-17 years old at the time of their visit.
  • Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.

Exclusion criteria

  • Eligibility will not be restricted by race or sex.
  • Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
  • Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.

Treatment and study plan

metabolic assessment

Other

Physical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc).

Questionnaire Administration

Other

Dietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2.

Other names: MAQA, AQA

Primary outcomes

  1. Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls

    Time frame: Day 1 and Day 2

  2. Insulin resistance (IR) in CCS vs controls

    Time frame: Day 1 and Day 2

  3. Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS

    Time frame: Day 1 and Day 2

  4. Dietary and a physical activity assessments of CCS vs controls

    Time frame: Day 1 and Day 2

Secondary outcomes

  1. Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS

    Time frame: Day 1 and Day 2

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Jun 15, 2009
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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