- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98105
- Clinical Research Center - Seattle Children's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Comparison of insulin resistance in patients with age- and gender-matched controls
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Influence of time since transplant on insulin resistance
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Peak growth hormone secretion in patients with insulin resistance and in those without
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Growth hormone deficiency in patients with metabolic syndrome and in those without
Tidsramme: ≥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
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Correlation of adiponectin with insulin resistance and central obesity
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
|
Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
Tidsramme: ≥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
Tidsramme: ≥2 years post-HSCT
|
≥2 years post-HSCT
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: K S Baker, MD, MS, Fred Hutchinson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- stadium I kronisk lymfatisk leukemi
- kreft overlevende
- akutt lymfatisk leukemi hos barn i remisjon
- barndom akutt myeloid leukemi i remisjon
- juvenil myelomonocytisk leukemi
- kronisk myelogen leukemi i barndommen
- metabolsk syndrom
- langtidseffekter sekundært til kreftbehandling hos barn
- stadium II kronisk lymfatisk leukemi
- stadium III kronisk lymfatisk leukemi
- stadium IV kronisk lymfatisk leukemi
- kardiovaskulære komplikasjoner
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IR 7141
- P30CA077598 (U.S. NIH-stipend/kontrakt)
- UMN-2003NT063
- CDR0000642276 (Registeridentifikator: NCI)
- IR-6980 (Annen identifikator: Former FHCRC IRB ID)
- FHCRC-2357.00 (Annen identifikator: Former FHCRC ID)
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