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

Leukemia Clinical Trial

Official title:

Metabolic Syndrome Following Transplant for Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920842
• Other study ID #: IR 7141
• Secondary ID: P30CA077598UMN-2
• Status: Completed
• Phase: N/A
• First received: June 12, 2009
• Last updated: November 29, 2012
• Start date: April 2005
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 21 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Clinical Research Center - Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		=2 years post-HSCT	No
Primary	Comparison of insulin resistance in patients with age- and gender-matched controls		=2 years post-HSCT	No
Primary	Correlation between insulin sensitivity and risk factors associated with metabolic syndrome		=2 years post-HSCT	No
Primary	Influence of time since transplant on insulin resistance		=2 years post-HSCT	No
Primary	Peak growth hormone secretion in patients with insulin resistance and in those without		=2 years post-HSCT	No
Primary	Growth hormone deficiency in patients with metabolic syndrome and in those without		=2 years post-HSCT	No
Primary	Association of interleukin-6, tumor necrosis factor-a, C-reactive protein, and leptin with insulin resistance and central obesity		=2 years post-HSCT	No
Primary	Correlation of adiponectin with insulin resistance and central obesity		=2 years post-HSCT	No
Primary	Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease		=2 years post-HSCT	No
Primary	Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without		=2 years post-HSCT	No