Clinical trial NCT01484873: Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Official title: Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Craniopharyngioma
Keywords: Exenatide
Byetta
Hypothalamic Obesity
Obesity
Craniopharyngioma
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.

Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.

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)

Primary outcomes:
measure: Body Weight (kg)
timeFrame: baseline, 50 weeks
Secondary outcomes:
measure: Resting Energy Expenditure (Kcals Per Day)
timeFrame: baseline, 50 weeks
measure: Visual Analogue Scales for Post-meal Satiety
timeFrame: baseline, 50 weeks
measure: Insulin Secretion (Area Under the Curve)
timeFrame: baseline, 50 weeks
measure: Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)
timeFrame: baseline, 50 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ashley Shoemaker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lomenick JP, Buchowski MS, Shoemaker AH. A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity. Obesity (Silver Spring). 2016 Jun;24(6):1222-5. doi: 10.1002/oby.21493. Epub 2016 May 2.