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

January 17, 2017 updated by: Ashley Shoemaker, Vanderbilt University Medical Center

Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exenatide
All patients received exenatide 10mcg BID x 50 weeks
Drug: Exenatide
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight (kg)
Time Frame: baseline, 50 weeks
Change in body weight from baseline to end of study
baseline, 50 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Energy Expenditure (Kcals Per Day)
Time Frame: baseline, 50 weeks
Change in resting energy expenditure from baseline to 50 weeks
baseline, 50 weeks
Visual Analogue Scales for Post-meal Satiety
Time Frame: baseline, 50 weeks
Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).
baseline, 50 weeks
Insulin Secretion (Area Under the Curve)
Time Frame: baseline, 50 weeks
Change in insulin secretion from baseline
baseline, 50 weeks
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)
Time Frame: baseline, 50 weeks
Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks
baseline, 50 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Ashley Shoemaker, M.D., Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (ESTIMATE)

December 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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