Status:
COMPLETED
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief 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.
Detailed Description
Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a conseq...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01484873
Start Date
June 1 2012
End Date
March 1 2015
Last Update
March 3 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232