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Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity


Phase 2
18 Years
40 Years
Open (Enrolling)
Both
Obesity, Overweight, Craniopharyngioma

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Trial Information

Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Body Weight (kg)

Outcome Description:

Change in body weight from baseline to end of study

Outcome Time Frame:

baseline and 52 weeks

Safety Issue:

No

Principal Investigator

Ashley Shoemaker, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University

Authority:

United States: Food and Drug Administration

Study ID:

111185

NCT ID:

NCT01484873

Start Date:

June 2012

Completion Date:

July 2014

Related Keywords:

  • Obesity
  • Overweight
  • Craniopharyngioma
  • Exenatide
  • Byetta
  • Hypothalamic Obesity
  • Obesity
  • Craniopharyngioma
  • Craniopharyngioma
  • Adamantinoma
  • Obesity
  • Overweight

Name

Location
Vanderbilt University Nashville, Tennessee  37232-6305