NCT00920738已完成不适用
Metabolic Syndrome in Childhood Cancer Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS
时间窗: Day 1 and Day 2
Dietary and a physical activity assessments of CCS vs controls
时间窗: Day 1 and Day 2
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls
时间窗: Day 1 and Day 2
Insulin resistance (IR) in CCS vs controls
时间窗: Day 1 and Day 2
次要结局
- Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS(Day 1 and Day 2)
研究者
研究点 (1)
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