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)