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Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant

2012年11月29日 更新者:Fred Hutchinson Cancer Center

Metabolic Syndrome Following Transplant for Leukemia

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.

研究概览

详细说明

OBJECTIVES:

  • To determine the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) and compare the extent to which prevalence is higher in HSCT survivors than in age- and gender-matched population norms derived from the Third National Health and Nutrition Examination Survey (NHANES III).
  • To evaluate the relationship between insulin resistance and risk factors associated with metabolic syndrome (e.g., hypertension, obesity, hyperinsulinemia, and dyslipidemia) as measured by euglycemic insulin clamp, fasting serum insulin, glucose, lipids (total cholesterol, triglycerides, LDL-C, and HDL-C), blood pressure and anthropometric measurements, and DEXA scan in these patients and compare to age- and gender-matched population norms.
  • To 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 metabolic syndrome and that may be altered after HSCT, including growth hormone secretion, adipokines (adiponectin and leptin), and inflammatory mediators (interleukin-6, tumor necrosis factor-α, and C-reactive protein).
  • To evaluate the association of metabolic syndrome and early signs of impaired endothelial function and cardiovascular changes.
  • To evaluate health behaviors related to prevention of cardiovascular disease, diabetes, and obesity, including a physical activity assessment, a dietary assessment, and a health knowledge assessment that will be used in the analyses of metabolic syndrome, growth hormone deficiency, and indicators of cardiovascular disease.

OUTLINE: Patients are stratified according to post-transplant follow-up period (2-9 years vs 10-15 years vs > 15 years).

Patients and their siblings undergo physical examination, a review of medical and family history, and blood pressure and anthropometric measurements. Patients and their siblings also undergo blood sample collection for laboratory studies (including analysis of C-reactive protein and CBC; lipid profile and triglycerides; leptin and adipokines; free thyroxine, TSH, IGF1, IGF3, and LH; and estradiol [females] or testosterone [males]); urine sample collection for microalbumin determination; and other study procedures (including euglycemic insulin clamp study; body composition and bone density [DEXA] study; bone-age x-ray [for patients < 18 years of age]; and vascular studies). Patients also undergo growth hormone stimulation testing.

Patients and their siblings complete questionnaires about their physical activity, dietary habits, and health knowledge.

PROJECTED ACCRUAL: A total of 193 childhood leukemia survivors and 193 healthy siblings will be accrued for this study.

研究类型

观察性的

注册 (实际的)

244

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Washington
      • Seattle、Washington、美国、98105
        • Clinical Research Center - Seattle Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9年 至 21年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Childhood leukemia survivors and healthy siblings, 9-21 years of age.

描述

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Survivor of childhood leukemia, meeting all of the following criteria:

      • 21 years of age and under at diagnosis
      • Has undergone hematopoietic stem cell transplantation (HSCT) at Fairview University Medical Center or Fred Hutchinson Cancer Research Center ≥ 2 years ago
      • Disease in remission
    • Healthy sibling of a childhood leukemia survivor

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Comparison of insulin resistance in patients with age- and gender-matched controls
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Influence of time since transplant on insulin resistance
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Peak growth hormone secretion in patients with insulin resistance and in those without
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Growth hormone deficiency in patients with metabolic syndrome and in those without
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Correlation of adiponectin with insulin resistance and central obesity
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
大体时间:≥2 years post-HSCT
≥2 years post-HSCT
Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without
大体时间:≥2 years post-HSCT
≥2 years post-HSCT

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:K S Baker, MD, MS、Fred Hutchinson Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年4月1日

初级完成 (实际的)

2011年7月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2009年6月12日

首先提交符合 QC 标准的

2009年6月12日

首次发布 (估计)

2009年6月15日

研究记录更新

最后更新发布 (估计)

2012年12月3日

上次提交的符合 QC 标准的更新

2012年11月29日

最后验证

2012年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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