Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Patients and sibling controls will be recruited from the Pediatric Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.

Detailed Description
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This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency matched by age and sex. Subjects in each group will have two visits. For cases, the first visit will be approximately 6 months after completion of treatment for ALL; for their siblings, the first visit occur at approximately the same time. For both cases and controls, the second visit will be 2 to 2.5 years after the first visit.

Official Title
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Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study

Conditions
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Acute Lymphoblastic Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients Age 7 years to less than or equal to 21 years at time of study enrollment. Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first complete remission. Any subtype is eligible. Study enrollment must take place at/after six months of completion of all chemotherapy. Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age. Any prior ALL therapy is allowable. Siblings Age 7 years to less than or equal to 21 years at time of study enrollment. Sibling of ALL patient. Exclusion Criteria: Patients Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study enrollment. Current pregnancy Prior hematopoietic cell transplant. Receiving growth hormone replacement or corticosteroids at the time of enrollment. Siblings Previously diagnosed with malignancy. Diagnosis of diabetes mellitus. Current pregnancy Receiving growth hormone replacement or corticosteroids at the time of enrollment.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sibling Controls<br>Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex. | |
| Acute Lymphoblastic Leukemia Survivors<br>Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic Profile | To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls. | up to 2.5-3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Blunted Stimulated Growth Hormone Response | To determine the prevalence of blunted stimulated GH response suggesting GH deficiency (peak GH <7mcg/L) in ALL survivors and controls: GH level will be obtained at baseline, then +30, +60, +90 and +120 minutes after clonidine (5 mcg/kg up to 200 mcg by mouth), followed by infusion of arginine (0.5 grams/kg up to 30 grams) with a series of GH levels at +140, +160, +180, +210, and +240 minutes. Blunted response to GH stimulation will be defined as peak GH level<7 mcg/L. | Between 2.5 and 3 Years |