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Metabolic Syndrome in Bone Marrow Transplant Survivors

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00855244
First received: March 3, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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. 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. 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.

Condition Intervention
Metabolic Syndrome
Other: Diagnostic exams

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Metabolic Syndrome in Bone Marrow Transplant Survivors

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • This information will be used to conduct a power analysis (Norton Power Software or NQuery Advisor) for design of a larger study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BMT survivors
Diagnostic exams
Other: Diagnostic exams
Growth hormone stimulation testing, oral glucose tolerance test, hyperinsulinemic euglycemic clamp

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855244

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital
Study Director: Amanda Termuhlen, MD Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Dana S. Hardin, MD/Associate Professor, The Research Institute at Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00855244     History of Changes
Other Study ID Numbers: IRB09-00023
Study First Received: March 3, 2009
Last Updated: March 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Bone marrow transplantation

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014