Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant
Condition: Cardiovascular Complications; Leukemia; Long-term Effects Secondary to Cancer Therapy in Children; Metabolic Syndrome
MeSH terms: Leukemia; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Childhood leukemia survivors and healthy siblings, 9-21 years of age.
      
Keywords: metabolic syndrome; long-term effects secondary to cancer therapy in children; cardiovascular complications; cancer survivor; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood chronic myelogenous leukemia; juvenile myelomonocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia