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Metabolic Syndrome in Childhood Cancer Survivors


N/A
9 Years
18 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Leukemia, Lymphoma, Metabolic Syndrome, Sarcoma

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Trial Information

Metabolic Syndrome in Childhood Cancer Survivors


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Day 1 and Day 2

Safety Issue:

No

Principal Investigator

Julia Steinberger, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2003NT064

NCT ID:

NCT00920738

Start Date:

April 2005

Completion Date:

June 2011

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Leukemia
  • Lymphoma
  • Metabolic Syndrome
  • Sarcoma
  • metabolic syndrome
  • cancer survivor
  • childhood soft tissue sarcoma
  • unspecified childhood solid tumor, protocol specific
  • childhood acute lymphoblastic leukemia
  • childhood chronic myelogenous leukemia
  • childhood Hodgkin lymphoma
  • childhood non-Hodgkin lymphoma
  • childhood acute myeloid leukemia/other myeloid malignancies
  • chronic lymphocytic leukemia
  • childhood brain stem glioma
  • childhood cerebellar astrocytoma
  • childhood cerebral astrocytoma/malignant glioma
  • childhood choroid plexus tumor
  • childhood craniopharyngioma
  • childhood embryonal tumor
  • childhood ependymoma
  • childhood oligodendroglioma
  • childhood pineal parenchymal tumor
  • childhood mixed glioma
  • childhood subependymal giant cell astrocytoma
  • childhood visual pathway and hypothalamic glioma
  • Leukemia
  • Lymphoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Metabolic Syndrome X
  • Sarcoma

Name

Location

University of Minnesota Children's Hospital - FairviewMinneapolis, Minnesota  55455