Adipokines as Predictors of the Metabolic Syndrome in ALL Survivors

Leukemia Clinical Trial

Official title:

Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00566566
• Other study ID #: SHEBA-07-4861-YW-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2007
• Last updated: November 30, 2007
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2007
• Source: Sheba Medical Center
• Contact: Bella Bielorai, MD
• Phone: 972-3-5302692
• Email: Bella.Bielorai[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 45 Years

Eligibility

Inclusion Criteria:

• ALL diagnosis

• five years after completion of treatment

• leukemia free during research

Exclusion Criteria:

• ongoing chemotherapy and radiotherapy

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Leukemia
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• sample without DNA
family history, anthropometric measurements and blood sampling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

References & Publications (11)

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Cook S, Weitzman M, Auinger P, Nguyen M, Dietz WH. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third National Health and Nutrition Examination Survey, 1988-1994. Arch Pediatr Adolesc Med. 2003 Aug;157(8):821-7. — View Citation

Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet. 2005 Apr 16-22;365(9468):1415-28. Review. — View Citation

Gurney JG, Ness KK, Sibley SD, O'Leary M, Dengel DR, Lee JM, Youngren NM, Glasser SP, Baker KS. Metabolic syndrome and growth hormone deficiency in adult survivors of childhood acute lymphoblastic leukemia. Cancer. 2006 Sep 15;107(6):1303-12. — View Citation

Koerner A, Kratzsch J, Kiess W. Adipocytokines: leptin--the classical, resistin--the controversical, adiponectin--the promising, and more to come. Best Pract Res Clin Endocrinol Metab. 2005 Dec;19(4):525-46. Review. — View Citation

Kourti M, Tragiannidis A, Makedou A, Papageorgiou T, Rousso I, Athanassiadou F. Metabolic syndrome in children and adolescents with acute lymphoblastic leukemia after the completion of chemotherapy. J Pediatr Hematol Oncol. 2005 Sep;27(9):499-501. — View Citation

Mohn A, Di Marzio A, Capanna R, Fioritoni G, Chiarelli F. Persistence of impaired pancreatic beta-cell function in children treated for acute lymphoblastic leukaemia. Lancet. 2004 Jan 10;363(9403):127-8. — View Citation

Oeffinger KC, Buchanan GR, Eshelman DA, Denke MA, Andrews TC, Germak JA, Tomlinson GE, Snell LE, Foster BM. Cardiovascular risk factors in young adult survivors of childhood acute lymphoblastic leukemia. J Pediatr Hematol Oncol. 2001 Oct;23(7):424-30. — View Citation

Pui CH, Cheng C, Leung W, Rai SN, Rivera GK, Sandlund JT, Ribeiro RC, Relling MV, Kun LE, Evans WE, Hudson MM. Extended follow-up of long-term survivors of childhood acute lymphoblastic leukemia. N Engl J Med. 2003 Aug 14;349(7):640-9. Erratum in: N Engl J Med. 2003 Sep 25;349(13):1299. — View Citation

Razzouk BI, Rose SR, Hongeng S, Wallace D, Smeltzer MP, Zacher M, Pui CH, Hudson MM. Obesity in survivors of childhood acute lymphoblastic leukemia and lymphoma. J Clin Oncol. 2007 Apr 1;25(10):1183-9. — View Citation

Taskinen M, Saarinen-Pihkala UM, Hovi L, Lipsanen-Nyman M. Impaired glucose tolerance and dyslipidaemia as late effects after bone-marrow transplantation in childhood. Lancet. 2000 Sep 16;356(9234):993-7. — View Citation

* Note: There are 11 references in all — Click here to view all references