Obesity Clinical Trial
Official title:
Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity
Verified date | April 2015 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Weight (kg) | Change in body weight from baseline to end of study | baseline and 52 weeks | No |
Secondary | Resting energy expenditure (kcals per day) | Change in resting energy expenditure from baseline to 50 weeks | baseline and 50 weeks | No |
Secondary | Visual analogue scales for satiety | Change in visual analogue scales scores from baseline to 50 weeks | baseline and 50 weeks | No |
Secondary | Insulin secretion (area under the curve) | 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. | baseline and 50 weeks | No |
Secondary | Gastric emptying rate (13C-octanoic acid isotope excretion half life) | Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks | baseline and 50 weeks | No |
Secondary | Glucagon secretion (area under the curve) | 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. | baseline and 50 weeks | No |
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