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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 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

244

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Washington
  - Seattle, Washington, États-Unis, 98105
    - Clinical Research Center - Seattle Children's Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

9 ans à 21 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fred Hutchinson Cancer Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

Chercheur principal: K S Baker, MD, MS, Fred Hutchinson Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2005

Achèvement primaire (Réel)

1 juillet 2011

Achèvement de l'étude (Réel)

1 novembre 2012

Dates d'inscription aux études

Première soumission

12 juin 2009

Première soumission répondant aux critères de contrôle qualité

12 juin 2009

Première publication (Estimation)

15 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 décembre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 novembre 2012

Dernière vérification