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Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant

29 novembre 2012 aggiornato da: Fred Hutchinson Cancer Center

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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

244

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • Clinical Research Center - Seattle Children's Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 9 anni a 21 anni (Bambino, Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Childhood leukemia survivors and healthy siblings, 9-21 years of age.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Comparison of insulin resistance in patients with age- and gender-matched controls
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Influence of time since transplant on insulin resistance
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Peak growth hormone secretion in patients with insulin resistance and in those without
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Growth hormone deficiency in patients with metabolic syndrome and in those without
Lasso di tempo: ≥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
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Correlation of adiponectin with insulin resistance and central obesity
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT
Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
Lasso di tempo: ≥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
Lasso di tempo: ≥2 years post-HSCT
≥2 years post-HSCT

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: K S Baker, MD, MS, Fred Hutchinson Cancer Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2005

Completamento primario (Effettivo)

1 luglio 2011

Completamento dello studio (Effettivo)

1 novembre 2012

Date di iscrizione allo studio

Primo inviato

12 giugno 2009

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2009

Primo Inserito (Stima)

15 giugno 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 dicembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 novembre 2012

Ultimo verificato

1 novembre 2012

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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