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

29 november 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

244

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Washington
  - Seattle, Washington, Verenigde Staten, 98105
    - Clinical Research Center - Seattle Children's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

9 jaar tot 21 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fred Hutchinson Cancer Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

Hoofdonderzoeker: K S Baker, MD, MS, Fred Hutchinson Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2005

Primaire voltooiing (Werkelijk)

1 juli 2011

Studie voltooiing (Werkelijk)

1 november 2012

Studieregistratiedata

Eerst ingediend

12 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria