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Adipokines as Predictors of the Metabolic Syndrome in ALL Survivors

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ClinicalTrials.gov Identifier: NCT00566566
Recruitment Status : Unknown
Verified November 2007 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 3, 2007
Last Update Posted : December 3, 2007
Information provided by:
Sheba Medical Center

Brief Summary:

Background: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for 25% of all childhood cancers. Peak incidence occurs between 2 to 5 years of age. Modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to current overall survival rates of approximately 80%.The high survival rates have introduced us to novel medical problems as a consequences of the different treatment regimens. No single treatment modality exists today but rather several treatment protocols are accepted worldwide. As such, the population of the childhood ALL survivors differ in their toxic exposure: cranial & spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone marrow transplantation .As the survival rates grow, there are more young adult ALL survivors worldwide susceptible to these late effects of treatment.

Numerous reports have pointed out that this particular group is at increased risk to develop cardiovascular disease (CVD) and diabetes (MS). The metabolic syndrome, i.e hypertension, dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the general population.

Adipocytokines, mediators secreted by adipose tissue, play an important role in the regulation of carbohydrates and lipid metabolism.Changes in serum adipokine levels precede the clinical symptoms.

We aim to identify and assess prevalence of the MS in ALL survivors. We aim to characterize the population at risk to develop DM and CVD prior to overt clinical disease. Characterization will be done by measuring serum adipocytokines and inflammatory cytokine profiles .Biochemical characterization of the group at risk will enable us to intervene in the preventive stage in the future.

Condition or disease Intervention/treatment
Leukemia Metabolic Syndrome X Other: sample without DNA

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Official Title: Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia
Study Start Date : January 2008
Estimated Study Completion Date : December 2008

Group/Cohort Intervention/treatment
ALL survivors 5 years after completion of treatment, during routine medical follow up
Other: sample without DNA
family history, anthropometric measurements and blood sampling

Biospecimen Retention:   Samples Without DNA
Serum leptin, resistin ,adiponectin ,CRP, PAI ,TNF-α, IL-6 will be taken as part of initial blood test screening in patients following an overnight fast. Adiponectin and leptin levels will be determined by RIA (Linco, St. Charles, MO), Insulin, will be determined by chemiluminescent immunometric method (Immulite 2000, Diagnostic Products Corporation, Los Angeles, CA).

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematoncological pediatric clinic

Inclusion Criteria:

  • ALL diagnosis
  • five years after completion of treatment
  • leukemia free during research

Exclusion Criteria:

  • ongoing chemotherapy and radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566566

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Contact: Bella Bielorai, MD 972-3-5302692 Bella.Bielorai@sheba.health.gov.il

Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Yael Weintraub, MD Tel Aviv University

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Responsible Party: Dr. Yael Weintraub, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT00566566    
Other Study ID Numbers: SHEBA-07-4861-YW-CTIL
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: December 3, 2007
Last Verified: November 2007
Keywords provided by Sheba Medical Center:
inflammatory markers
cardiovascular disease
diabetes mellitus
Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Syndrome
Pathologic Processes
Neoplasms by Histologic Type
Glucose Metabolism Disorders
Metabolic Diseases