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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

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 Summary:

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.


Sponsor: Vanderbilt University Medical Center

Current Primary Outcome: Body Weight (kg) [ Time Frame: baseline, 50 weeks ]

Change in body weight from baseline to end of study


Original Primary Outcome: Body Weight (kg) [ Time Frame: baseline and 52 weeks ]

Change in body weight from baseline to end of study


Current Secondary Outcome:

  • Resting Energy Expenditure (Kcals Per Day) [ Time Frame: baseline, 50 weeks ]
    Change in resting energy expenditure from baseline to 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).
  • Insulin Secretion (Area Under the Curve) [ Time Frame: baseline, 50 weeks ]
    Change in insulin secretion from baseline
  • 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


Original Secondary Outcome:

  • Resting Energy Expenditure (Kcals Per Day) [ Time Frame: baseline and 50 weeks ]
    Change in resting energy expenditure from baseline to 50 weeks
  • Free-living energy expenditure (kcals per day) [ Time Frame: baseline and 50 weeks ]
    Change in free-living energy expenditure from baseline to 50 weeks
  • Visual analogue scales for satiety [ Time Frame: baseline and 50 weeks ]
    Change in visual analogue scales scores from baseline to 50 weeks
  • Insulin Secretion (Area Under the Curve) [ Time Frame: baseline and 50 weeks ]
    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 ]
    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 ]
    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.
  • GLP-1 secretion (area under the curve) [ Time Frame: baseline and 50 weeks ]
    GLP-1 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.
  • Ghrelin secretion (area under the curve) [ Time Frame: baseline and 50 weeks ]
    Ghrelin 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.


Information By: Vanderbilt University Medical Center

Dates:
Date Received: October 20, 2011
Date Started: June 2012
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017