Effects of Exenatide on Hypothalamic Obesity
The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index [BMI]) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their BMI significantly from baseline.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Exenatide on Hypothalamic Obesity|
- Change in age- and sex-adjusted BMI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||February 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the GLP-1 circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite.
|United States, Minnesota|
|Children's Hospitals & Clincis of Minnesota|
|St. Paul, Minnesota, United States, 55102|
|Principal Investigator:||M. Jennifer Abuzzahab, MD||Children's Hospitals & Clinics of Minnesota|