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

NCT ID: NCT01484873

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-03-31

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.

Conditions

Obesity; Overweight; Craniopharyngioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exenatide

All patients received exenatide 10mcg BID x 50 weeks

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Interventions

Exenatide

Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Intervention Type: DRUG

Other Intervention Names

Byetta

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ashley Shoemaker

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley Shoemaker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27133664 (View on PubMed)

Other Identifiers

111185

Identifier Type: -

Identifier Source: org_study_id