Metabolic Syndrome in Childhood Cancer Survivors

University of Minnesota (UMN)

Status

Completed

Conditions

Sarcoma

Brain and Central Nervous System Tumors

Lymphoma

Leukemia

Metabolic Syndrome

Treatments

Other: metabolic assessment

Other: questionnaire administration

Study type

Observational

Funder types

Other

Identifiers

NCT00920738

0411M65666 (Other Identifier)

2003NT064

Details and patient eligibility

About

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.

Full 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.

Enrollment

512 patients

Sex

All

Ages

9 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.