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Metabolic Syndrome in Childhood Cancer Survivors

Metabolic Syndrome in Childhood Cancer Survivors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00920738
Enrollment
512
Registered
2009-06-15
Start date
2005-04-30
Completion date
2011-06-30
Last updated
2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors, Leukemia, Lymphoma, Metabolic Syndrome, Sarcoma

Keywords

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

Brief summary

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.

Detailed description

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.

Interventions

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).

OTHERquestionnaire administration

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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controlsDay 1 and Day 2
Insulin resistance (IR) in CCS vs controlsDay 1 and Day 2
Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCSDay 1 and Day 2
Dietary and a physical activity assessments of CCS vs controlsDay 1 and Day 2

Secondary

MeasureTime frame
Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCSDay 1 and Day 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026