Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant
|ClinicalTrials.gov Identifier: NCT00920842|
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : December 3, 2012
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.
|Condition or disease|
|Cardiovascular Complications Leukemia Long-term Effects Secondary to Cancer Therapy in Children Metabolic Syndrome|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||244 participants|
|Observational Model:||Case Control|
|Official Title:||Metabolic Syndrome Following Transplant for Leukemia|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||November 2012|
- 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 [ Time Frame: ≥2 years post-HSCT ]
- Comparison of insulin resistance in patients with age- and gender-matched controls [ Time Frame: ≥2 years post-HSCT ]
- Correlation between insulin sensitivity and risk factors associated with metabolic syndrome [ Time Frame: ≥2 years post-HSCT ]
- Influence of time since transplant on insulin resistance [ Time Frame: ≥2 years post-HSCT ]
- Peak growth hormone secretion in patients with insulin resistance and in those without [ Time Frame: ≥2 years post-HSCT ]
- Growth hormone deficiency in patients with metabolic syndrome and in those without [ Time Frame: ≥2 years post-HSCT ]
- Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity [ Time Frame: ≥2 years post-HSCT ]
- Correlation of adiponectin with insulin resistance and central obesity [ Time Frame: ≥2 years post-HSCT ]
- Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease [ Time Frame: ≥2 years post-HSCT ]
- Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without [ Time Frame: ≥2 years post-HSCT ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920842
|United States, Washington|
|Clinical Research Center - Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||K S Baker, MD, MS||Fred Hutchinson Cancer Research Center|