Metabolic Syndrome in Bone Marrow Transplant Survivors

NCT00855244 | Terminated

• 1 other identifier: IRB09-00023
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Life for long-term bone marrow transplant patients is complicated by endocrine late effects including growth hormone (GH) deficiency, thyroid hormone deficiency and sex steroid deficiency. Recently, studies have also identified problems with metabolic syndrome in adult bone marrow transplant (BMT) survivors. Metabolic syndrome has been identified as a constellation of insulin resistance, truncal obesity and high lipid levels (dyslipidemia) and is associated with an increased risk of type 2 diabetes and cardiovascular disease. Thus the early identification of metabolic syndrome is important. To date, studies have not identified how young an age metabolic syndrome begins in BMT survivors. The investigators' study will consist of two aims:

1. 1.Evaluation of children who have survived BMT for growth hormone deficiency, abnormal lipid metabolism, hypothyroidism and gonadal dysgenesis. The investigators will utilize growth hormone stimulation testing, sex steroid levels, an oral glucose tolerance test (OGTT) and fasting lipid profile to evaluate for concomitant endocrinopathy, prediabetes and impaired glucose tolerance in a cohort of BMT survivors.
2. 2.Cross-sectional study of peripheral and hepatic insulin sensitivity in children surviving BMT using a hyperinsulinemic euglycemic clamp and the stable isotope 6,6 \[2H2\] glucose. These aims will provide pilot data to power the first definitive study of insulin resistance in childhood BMT survivors.

Conditions

Metabolic Syndrome

Keywords

Bone marrow transplantation

Outcome Measures

Primary Outcomes (1)

• This information will be used to conduct a power analysis (Norton Power Software or NQuery Advisor) for design of a larger study.

  1 year

Study Arms (1)

BMT survivors

OTHER

Diagnostic exams

Other: Diagnostic exams

Interventions

Diagnostic exams OTHER

Growth hormone stimulation testing, oral glucose tolerance test, hyperinsulinemic euglycemic clamp

BMT survivors

Eligibility Criteria

• Age: 9 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• One year post BMT in autogenic transplanted patients and two years from BMT in allogenic transplanted patients
• The participants may be from any ethnic group and of either gender
• Free of the following chronic medical illness (diseases possibly associated with glucose intolerance or altered insulin sensitivity): type 1 DM, HIV, chronic liver disease, cystic fibrosis, chronic renal failure, known genetic syndrome.

You may not qualify if:

• On-going graft vs. host disease
• Use of Megace® or another progestational agent
• Use of anabolic steroids
• Diagnosis of one of the chronic diseases listed above

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (3)

• Meacham L. Endocrine late effects of childhood cancer therapy. Curr Probl Pediatr Adolesc Health Care. 2003 Aug;33(7):217-42. doi: 10.1016/s1538-5442(03)00053-1. No abstract available.

  PMID: 12902974 BACKGROUND

• Oberfield SE, Sklar CA. Endocrine sequelae in survivors of childhood cancer. Adolesc Med. 2002 Feb;13(1):161-9, viii.

  PMID: 11841962 BACKGROUND

• Taskinen M, Lipsanen-Nyman M, Tiitinen A, Hovi L, Saarinen-Pihkala UM. Insufficient growth hormone secretion is associated with metabolic syndrome after allogeneic stem cell transplantation in childhood. J Pediatr Hematol Oncol. 2007 Aug;29(8):529-34. doi: 10.1097/MPH.0b013e3180f61b67.

  PMID: 17762493 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Amanda Termuhlen, MD

  Nationwide Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

US (1)