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Metabolic Syndrome Following Transplant for Leukemia

9 Years
21 Years
Not Enrolling
Cardiovascular Complications, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Metabolic Syndrome

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Trial Information

Metabolic Syndrome Following Transplant for Leukemia


- 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.

Inclusion Criteria


- 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


- Not pregnant

- Negative pregnancy test


- See Disease Characteristics

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

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

Outcome Time Frame:

≥2 years post-HSCT

Safety Issue:


Principal Investigator

K S Baker, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:

IR 7141



Start Date:

April 2005

Completion Date:

November 2012

Related Keywords:

  • Cardiovascular Complications
  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Metabolic Syndrome
  • metabolic syndrome
  • long-term effects secondary to cancer therapy in children
  • cardiovascular complications
  • cancer survivor
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood chronic myelogenous leukemia
  • juvenile myelomonocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Metabolic Syndrome X



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