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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00920842
First received: June 12, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Cardiovascular Complications
Leukemia
Long-term Effects Secondary to Cancer Therapy in Children
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Metabolic Syndrome Following Transplant for Leukemia

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Comparison of insulin resistance in patients with age- and gender-matched controls [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • Correlation between insulin sensitivity and risk factors associated with metabolic syndrome [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • Influence of time since transplant on insulin resistance [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • Peak growth hormone secretion in patients with insulin resistance and in those without [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • Growth hormone deficiency in patients with metabolic syndrome and in those without [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlation of adiponectin with insulin resistance and central obesity [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease [ Time Frame: ≥2 years post-HSCT ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: April 2005
Study Completion Date: November 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   9 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920842

Locations
United States, Washington
Clinical Research Center - Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: K S Baker, MD, MS Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: K. S. Baker, MD, MS, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00920842     History of Changes
Other Study ID Numbers: IR 7141, P30CA077598, UMN-2003NT063, CDR0000642276, IR-6980, FHCRC-2357.00
Study First Received: June 12, 2009
Last Updated: November 29, 2012
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
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

Additional relevant MeSH terms:
Metabolic Syndrome X
Leukemia
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014