Clinical trial NCT00920842: Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant
Official title: Metabolic Syndrome Following Transplant for Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Complications
Leukemia
Long-term Effects Secondary to Cancer Therapy in Children
Metabolic Syndrome
Keywords: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-06-15
Enrollment: 244
Sex: ALL
Minimum age (years): 9
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood leukemia survivors and healthy siblings, 9-21 years of age.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: ≥2 years post-HSCT
measure: Comparison of insulin resistance in patients with age- and gender-matched controls
timeFrame: ≥2 years post-HSCT
measure: Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
timeFrame: ≥2 years post-HSCT
measure: Influence of time since transplant on insulin resistance
timeFrame: ≥2 years post-HSCT
measure: Peak growth hormone secretion in patients with insulin resistance and in those without
timeFrame: ≥2 years post-HSCT
measure: Growth hormone deficiency in patients with metabolic syndrome and in those without
timeFrame: ≥2 years post-HSCT
measure: Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity
timeFrame: ≥2 years post-HSCT
measure: Correlation of adiponectin with insulin resistance and central obesity
timeFrame: ≥2 years post-HSCT
measure: Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
timeFrame: ≥2 years post-HSCT
measure: Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without
timeFrame: ≥2 years post-HSCT
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Clinical Research Center - Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: K S Baker, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: