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临床试验/NCT00920842
NCT00920842已完成不适用

Metabolic Syndrome Following Transplant for Leukemia

Fred Hutchinson Cancer Center1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
244
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
9 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: ≥2 years post-HSCT

Comparison of insulin resistance in patients with age- and gender-matched controls

时间窗: ≥2 years post-HSCT

Correlation between insulin sensitivity and risk factors associated with metabolic syndrome

时间窗: ≥2 years post-HSCT

Influence of time since transplant on insulin resistance

时间窗: ≥2 years post-HSCT

Peak growth hormone secretion in patients with insulin resistance and in those without

时间窗: ≥2 years post-HSCT

Growth hormone deficiency in patients with metabolic syndrome and in those without

时间窗: ≥2 years post-HSCT

Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity

时间窗: ≥2 years post-HSCT

Correlation of adiponectin with insulin resistance and central obesity

时间窗: ≥2 years post-HSCT

Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease

时间窗: ≥2 years post-HSCT

Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without

时间窗: ≥2 years post-HSCT

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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