Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
This study is currently recruiting participants.
Verified June 2012 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
Jefferson Lomenick
Information provided by (Responsible Party):
Ashley Shoemaker, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01484873
First received: October 20, 2011
Last updated: June 20, 2012
Last verified: June 2012
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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: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484873
Contacts
| Contact: Ashley Shoemaker, M.D. | 615-343-8116 | ashley.h.shoemaker@vanderbilt.edu |
Locations
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Ashley Shoemaker, M.D. 615-343-8116 ashley.h.shoemaker@vanderbilt.edu | |
| Principal Investigator: Ashley Shoemaker, M.D. | |
Sponsors and Collaborators
Vanderbilt University
Jefferson Lomenick
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: | June 20, 2012 |
| 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 |
ClinicalTrials.gov processed this record on June 17, 2013