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

Primary Purpose

Obesity, Overweight, Craniopharyngioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Exenatide, Byetta, Hypothalamic Obesity, Obesity, Craniopharyngioma

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exenatide

Arm Description

All patients received exenatide 10mcg BID x 50 weeks

Outcomes

Primary Outcome Measures

Body Weight (kg)
Change in body weight from baseline to end of study

Secondary Outcome Measures

Resting Energy Expenditure (Kcals Per Day)
Change in resting energy expenditure from baseline to 50 weeks
Visual Analogue Scales for Post-meal Satiety
Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).
Insulin Secretion (Area Under the Curve)
Change in insulin secretion from baseline
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

Full Information

First Posted
October 20, 2011
Last Updated
January 17, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01484873
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Craniopharyngioma
Keywords
Exenatide, Byetta, Hypothalamic Obesity, Obesity, Craniopharyngioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Experimental
Arm Description
All patients received exenatide 10mcg BID x 50 weeks
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Primary Outcome Measure Information:
Title
Body Weight (kg)
Description
Change in body weight from baseline to end of study
Time Frame
baseline, 50 weeks
Secondary Outcome Measure Information:
Title
Resting Energy Expenditure (Kcals Per Day)
Description
Change in resting energy expenditure from baseline to 50 weeks
Time Frame
baseline, 50 weeks
Title
Visual Analogue Scales for Post-meal Satiety
Description
Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).
Time Frame
baseline, 50 weeks
Title
Insulin Secretion (Area Under the Curve)
Description
Change in insulin secretion from baseline
Time Frame
baseline, 50 weeks
Title
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)
Description
Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks
Time Frame
baseline, 50 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Shoemaker, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27133664
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.
Results Reference
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Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

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