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

Obesity Clinical Trial

Official title:

Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484873
• Other study ID #: 111185
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2011
• Last updated: April 2, 2015
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Craniopharyngioma
• Obesity
• Overweight

Intervention

Drug:
• Exenatide
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight (kg)	Change in body weight from baseline to end of study	baseline and 52 weeks	No
Secondary	Resting energy expenditure (kcals per day)	Change in resting energy expenditure from baseline to 50 weeks	baseline and 50 weeks	No
Secondary	Visual analogue scales for satiety	Change in visual analogue scales scores from baseline to 50 weeks	baseline and 50 weeks	No
Secondary	Insulin secretion (area under the curve)	Insulin secretion will be measured at 0, 30, 60, 90 and 120 minutes during an oral glucose tolerance test and AUC will be determined at baseline and 50 weeks.	baseline and 50 weeks	No
Secondary	Gastric emptying rate (13C-octanoic acid isotope excretion half life)	Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks	baseline and 50 weeks	No
Secondary	Glucagon secretion (area under the curve)	Glucagon secretion will be measured at 0, 30, 60, 90 and 120 minutes during an oral glucose tolerance test and AUC will be determined at baseline and 50 weeks.	baseline and 50 weeks	No

External Links

•   Research lab website
•   Vanderbilt Pediatric Endocrinology website