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NCT Number: NCT00920842

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

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.

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Key information

Conditions

Cardiovascular Complications Bone Marrow Diseases Chronic Disease Disease Attributes Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hyperinsulinism Immune System Diseases Immunoproliferative Disorders Insulin Resistance Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myelomonocytic, Juvenile Long-term Effects Secondary to Cancer Therapy in Children Lymphatic Diseases Lymphoproliferative Disorders Metabolic Diseases Metabolic Syndrome Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

9 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Center - Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: ≥2 years post-HSCT

  2. Comparison of insulin resistance in patients with age- and gender-matched controls

    Time frame: ≥2 years post-HSCT

  3. Correlation between insulin sensitivity and risk factors associated with metabolic syndrome

    Time frame: ≥2 years post-HSCT

  4. Influence of time since transplant on insulin resistance

    Time frame: ≥2 years post-HSCT

  5. Peak growth hormone secretion in patients with insulin resistance and in those without

    Time frame: ≥2 years post-HSCT

  6. Growth hormone deficiency in patients with metabolic syndrome and in those without

    Time frame: ≥2 years post-HSCT

  7. Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity

    Time frame: ≥2 years post-HSCT

  8. Correlation of adiponectin with insulin resistance and central obesity

    Time frame: ≥2 years post-HSCT

  9. Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease

    Time frame: ≥2 years post-HSCT

  10. Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without

    Time frame: ≥2 years post-HSCT

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Metabolic Syndrome Following Transplant for Leukemia

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Jun 15, 2009
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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