Adipokines as Predictors of the Metabolic Syndrome in ALL Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00566566
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention
Leukemia
Metabolic Syndrome X
Other: sample without DNA

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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).


Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: December 2008
Groups/Cohorts Assigned Interventions
1
ALL survivors 5 years after completion of treatment, during routine medical follow up
Other: sample without DNA
family history, anthropometric measurements and blood sampling

  Eligibility

Ages Eligible for Study:   6 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hematoncological pediatric clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • ongoing chemotherapy and radiotherapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00566566

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

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

Publications:

Responsible Party: Dr. Yael Weintraub, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT00566566     History of Changes
Other Study ID Numbers: SHEBA-07-4861-YW-CTIL
Study First Received: November 30, 2007
Last Updated: November 30, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
adipocytokines
inflammatory markers
cardiovascular disease
diabetes mellitus
Leptin

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

ClinicalTrials.gov processed this record on September 18, 2014