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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ashley Shoemaker, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01484873
First received: October 20, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Overweight
Craniopharyngioma
Drug: Exenatide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Body Weight (kg) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline to end of study


Secondary Outcome Measures:
  • Resting energy expenditure (kcals per day) [ Time Frame: baseline and 50 weeks ] [ Designated as safety issue: No ]
    Change in resting energy expenditure from baseline to 50 weeks

  • Visual analogue scales for satiety [ Time Frame: baseline and 50 weeks ] [ Designated as safety issue: No ]
    Change in visual analogue scales scores from baseline to 50 weeks

  • Insulin secretion (area under the curve) [ Time Frame: baseline and 50 weeks ] [ Designated as safety issue: No ]
    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.

  • Gastric emptying rate (13C-octanoic acid isotope excretion half life) [ Time Frame: baseline and 50 weeks ] [ Designated as safety issue: No ]
    Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks

  • Glucagon secretion (area under the curve) [ Time Frame: baseline and 50 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide Drug: Exenatide
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Other Name: Byetta

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484873

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Ashley Shoemaker, M.D. Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Ashley Shoemaker, Clinical Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01484873     History of Changes
Other Study ID Numbers: 111185
Study First Received: October 20, 2011
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Exenatide
Byetta
Hypothalamic Obesity
Obesity
Craniopharyngioma

Additional relevant MeSH terms:
Craniopharyngioma
Adamantinoma
Obesity
Overweight
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014