Clinical trial NCT00920738: Metabolic Syndrome in Childhood Cancer Survivors
Official title: Metabolic Syndrome in Childhood Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 512
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The childhood cancer survivor (CCS) subjects for this study will be selected from Pediatric Oncology databases at the University of Minnesota Medical Center and Children"s Hospitals and Clinics of Minneapolis and St. Paul as described previously. CCS will complete a comprehensive evaluation in the Masonic Clinical Research Unit (MCRU) over a 2 day time period. The comparative data on normal children and adolescents will be obtained from healthy siblings frequency matched by age and gender and who will be evaluated in a manner similar to the CCS.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls
timeFrame: Day 1 and Day 2
measure: Insulin resistance (IR) in CCS vs controls
timeFrame: Day 1 and Day 2
measure: Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS
timeFrame: Day 1 and Day 2
measure: Dietary and a physical activity assessments of CCS vs controls
timeFrame: Day 1 and Day 2
Secondary outcomes:
measure: Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Children's Hospital - Fairview
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Julia Steinberger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: