Phase 2
N=19
Effects of Exenatide on Hypothalamic Obesity
Hypothalamic Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01061775 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Mar 2016
Primary outcome: Primary: BMI Change — -0.77 kg/m^2 — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospitals and Clinics of Minnesota
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMI Change |
-0.77 | .05 |
| PRIMARY Waist to Height Ratio (WHtR) |
-2.06 | 0.05 |
| SECONDARY Childhood Eating Behavior Questionnaire (CEBQ) |
14 | 0.05 |
| SECONDARY Calorie Intake Based on 3-day Diet Records |
406.700 | 0.05 |
Summary
The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) 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 body mass index significantly from baseline.
Eligibility Criteria
Inclusion Criteria
- >/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
- 10-21 years old
- Age-and sex-adjusted BMI >/=95%
- Parent sign consent and patient sign assent
Exclusion Criteria
- < 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
- Pregnant or breastfeeding, or those women who plan to get pregnant
- Renal impairment
- Gastroparesis
- Pancreatitis
- Diabetes
- <1 month post initiation of Metformin treatment
- Prescription or over-the-counter weight loss medications within 3 months of screening
- Are actively participating in, or have participated in a formal weight loss program within the last 3 months
- Have had bariatric surgery
Data sourced from ClinicalTrials.gov (NCT01061775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.