Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
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 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|
- Body Weight (kg) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]Change in body weight from baseline to end of study
- 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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Other Name: Byetta
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.
|Contact: Ashley Shoemaker, M.D.||firstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Ashley Shoemaker, M.D. 615-343-8116 email@example.com|
|Principal Investigator: Ashley Shoemaker, M.D.|
|Principal Investigator:||Ashley Shoemaker, M.D.||Vanderbilt University|