Metabolic Syndrome in Childhood Cancer Survivors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
Primary
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Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
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Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
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Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
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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).
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer Survivors Subjects who are cancer survivors must have survived childhood cancer (diagnosed < or = 18 years) for a minimum of 5 years and be in remission. |
Other: metabolic assessment
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).
Other: questionnaire 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.
Other Names:
|
| Healthy Siblings of Cancer Survivor Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings. |
Other: metabolic assessment
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).
Other: questionnaire 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls [Day 1 and Day 2]
- Insulin resistance (IR) in CCS vs controls [Day 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 CCS [Day 1 and Day 2]
- Dietary and a physical activity assessments of CCS vs controls [Day 1 and Day 2]
Secondary Outcome Measures
- Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS [Day 1 and Day 2]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Subjects will be 9-17 years old at the time of their visit.
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Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.
Exclusion Criteria:
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Eligibility will not be restricted by race or sex.
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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.
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Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota Children's Hospital - Fairview | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Julia Steinberger, MD, MS, Masonic Cancer Center, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2003NT064
- 0411M65666