- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00920842
Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Clinical Research Center - Seattle Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Comparison of insulin resistance in patients with age- and gender-matched controls
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Influence of time since transplant on insulin resistance
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Peak growth hormone secretion in patients with insulin resistance and in those without
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Growth hormone deficiency in patients with metabolic syndrome and in those without
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Correlation of adiponectin with insulin resistance and central obesity
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without
Periodo de tiempo: ≥2 years post-HSCT
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≥2 years post-HSCT
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: K S Baker, MD, MS, Fred Hutchinson Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- leucemia linfocítica crónica en estadio I
- sobreviviente de cáncer
- leucemia linfoblástica aguda infantil en remisión
- leucemia mieloide aguda infantil en remisión
- leucemia mielomonocítica juvenil
- leucemia mieloide cronica infantil
- síndrome metabólico
- efectos a largo plazo secundarios a la terapia del cáncer en niños
- leucemia linfocítica crónica en estadio II
- leucemia linfocítica crónica en estadio III
- leucemia linfocítica crónica en estadio IV
- complicaciones cardiovasculares
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IR 7141
- P30CA077598 (Subvención/contrato del NIH de EE. UU.)
- UMN-2003NT063
- CDR0000642276 (Identificador de registro: NCI)
- IR-6980 (Otro identificador: Former FHCRC IRB ID)
- FHCRC-2357.00 (Otro identificador: Former FHCRC ID)
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