Overview

Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vanderbilt University
Vanderbilt University Medical Center
Treatments:
Exenatide
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)