Condition or Therapy:
Craniopharyngiomas, hypothalamic obesity
What is the goal of this study?
Structural damage in the hypothalamus of the brain after craniopharyngiomas often lead to uncontrolled appetite, rapid weight gain, disturbances of body weight-regulating hormones, decreased sympathetic activity, low energy expenditure, and increased energy storage in adipose tissue. We have pilot data in humans that suggest benefits of glucagon-like peptide 1 receptor (GLP-1R) agonist administration in this population.
The aim of this study is to test the effects of once weekly exenatide on body mass index (BMI), risk factors for cardiovascular disease, and energy balance. We also plan to identify predictors of GLP-1R agonist treatment success in patients with hypothalamic obesity.
Who can join the study?
- Patients with a confirmed diagnosis of hypothalamic obesity after craniopharyngioma
- Age 10-25 years
- Age- and sex-adjusted BMI ≥95% or BMI ≥30 kg/m2 if over 18 years
- ≥6 months post-surgical or radiation treatment
Note: Other criteria apply and will be explained prior to screening.
What happens in the study?
Participation in the study will last 56 weeks. This study includes travelling to one of the three research centers (Seattle, Nashville, St Paul) for a screening visit and 5 study visits over the course of one year.
Visits last from 1-7 hours and may include lab tests (including oral glucose tolerance testing at 3 visits), electrocardiograms, body measurements, questionnaires, vital signs, body composition (DXA) scans, bone age x-rays, urine specimen collection, test meals, and physical exams.
This is a double-blinded trial for the first 36 weeks; and open label for the final 18 weeks of the study.
Who can I contact for information or to enroll?
To learn about the ECHO Study, please contact the study coordinator at one of the participating centers:
Vanderbilt University Medical Center
Seattle Children's main campus, Children’s Minnesota, and Vanderbilt University Medical Center
Dr. Christian Roth