Intranasal Oxytocin in Hypothalamic Obesity

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The purpose of this research study is to find out if intranasal oxytocin (the hormone oxytocin, delivered through a nasal spray solution) will help with easy weight gain in children, adolescents, and adults with brain tumors and hypothalamic obesity syndrome. In children and adolescents with hypothalamic obesity syndrome, the production of oxytocin may be too low. Oxytocin is important for the body’s metabolism, or use of energy. Low oxytocin production could be a cause of easy weight gain in people with hypothalamic obesity syndrome. Participants will undergo a telephone screening and then an in-person screening visit to determine eligibility. Subjects will be randomized and begin 8 weeks of treatment with either Oxytocin or placebo. After a 4-week "washout", participants will cross-over to 8 weeks of treatment with the other condition (i.e., placebo or OXT). The proposed study has the potential to identify a rational, effective, and safe treatment strategy for a highly morbid condition for which no alternatives currently exist.

Eligibility & Criteria

IRB #:
16-012730
Official Title:
Intranasal Oxytocin to Promote Weight Loss in Children, Adolescents, and Adults with Brain Tumors and Hypothalamic Obesity Syndrome
Study Phase:
Phase II
Eligible Age Range:
10 - 35 Years
Gender:
All
Study Categories: