Metabolic Syndrome in Childhood Cancer Survivors

NCT ID: NCT00920738

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 512 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

metabolic assessment

Intervention Type: OTHER

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).

questionnaire administration

Intervention Type: OTHER

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.

Healthy Siblings of Cancer Survivor

Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings.

metabolic assessment

Intervention Type: OTHER

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).

questionnaire administration

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

MAQA; AQA

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Steinberger, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota Children's Hospital - Fairview

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0411M65666

Identifier Type: OTHER

Identifier Source: secondary_id

2003NT064

Identifier Type: -

Identifier Source: org_study_id