Phase 2
N=10
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Obesity · Overweight · Craniopharyngioma
Bottom Line
View on ClinicalTrials.gov: NCT01484873 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Body Weight (kg) — -1.4 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight (kg) |
-1.4 | — |
| SECONDARY Resting Energy Expenditure (Kcals Per Day) |
-157.7 | — |
| SECONDARY Visual Analogue Scales for Post-meal Satiety |
-2.5 | — |
| SECONDARY Insulin Secretion (Area Under the Curve) |
-89.3 | — |
| SECONDARY Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life) |
12.9 | — |
Summary
The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 40 years old
- History of craniopharyngioma or other lesion in the hypothalamic region
- Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
- BMI >30 mg/m2
- Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks
Exclusion Criteria
- HgbA1C >7%
- Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
- Use of weight loss drugs or initiation of a weight loss program in past 3 months
- Impaired renal function or history of kidney transplant
- History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
- Personal or family history of medullary carcinoma of the thyroid or MEN type 2
- History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility
- History of allergic reaction to exenatide or other medication components
- Other significant comorbidities other than pituitary deficiencies
- Currently prescribed warfarin (exenatide may alter warfarin metabolism)
- Pregnant or lactating females
- History of severe hypoglycemia (BG <60 and requiring assistance from another person)
Data sourced from ClinicalTrials.gov (NCT01484873). 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.