Metabolic Syndrome in Bone Marrow Transplant Survivors
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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:
- 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.
- 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 |
- 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 |
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| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| 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 Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013