Metabolic Syndrome in Bone Marrow Transplant Survivors
Stopped early · Not applicable
Conditions studied: Metabolic Syndrome
In brief
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.
Key facts
- Study ID
- NCT00855244
- Run by
- Nationwide Children's Hospital
- People needed
- 5
- Starts
- 2009-03-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2015-05-18
Who can join
Age: 9 and older, up to 23. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.