Metabolic Syndrome in Childhood Cancer Survivors

Lymphoma Clinical Trial

Official title:

Metabolic Syndrome in Childhood Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920738
• Other study ID #: 2003NT064
• Secondary ID: 0411M65666
• Status: Completed
• Phase: N/A
• First received: June 12, 2009
• Last updated: August 21, 2014
• Start date: April 2005
• Est. completion date: June 2011

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: June 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Leukemia
• Lymphoma
• Metabolic Syndrome
• Metabolic Syndrome X
• Nervous System Neoplasms
• Sarcoma
• Syndrome

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota Children's Hospital - Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls		Day 1 and Day 2	No
Primary	Insulin resistance (IR) in CCS vs controls		Day 1 and Day 2	No
Primary	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	No
Primary	Dietary and a physical activity assessments of CCS vs controls		Day 1 and Day 2	No
Secondary	Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS		Day 1 and Day 2	No