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

Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01484873

Enrollment

Registered

2011-12-02

Start date

2012-06-30

Completion date

2015-03-31

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniopharyngioma, Obesity, Overweight

Keywords

Exenatide, Byetta, Hypothalamic Obesity, Obesity, Craniopharyngioma

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 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.

Interventions

DRUGExenatide

Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Body Weight (kg)	baseline, 50 weeks	Change in body weight from baseline to end of study

Secondary

Measure	Time frame	Description
Resting Energy Expenditure (Kcals Per Day)	baseline, 50 weeks	Change in resting energy expenditure from baseline to 50 weeks
Visual Analogue Scales for Post-meal Satiety	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)	baseline, 50 weeks	Change in insulin secretion from baseline
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)	baseline, 50 weeks	Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks

Countries

United States

Participant flow

Recruitment details

University clinics and online advertisements from June, 2012 - March, 2013

Participants by arm

Arm	Count
Exenatide exenatide 10 mcg twice daily	10
Total	10

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Exenatide
Age, Categorical <=18 years	2 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Gastric emptying half life	175.4 minutes STANDARD_DEVIATION 81
Gender Female	7 Participants
Gender Male	3 Participants
Insulin AUC	13076 120 min*uU/mL STANDARD_DEVIATION 7482
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	10 Participants
Region of Enrollment United States	10 participants
Resting energy expenditure	2215.0 kcal/day STANDARD_DEVIATION 654.9
Satiety	68.9 mm STANDARD_DEVIATION 15.4
Weight	137.2 kg STANDARD_DEVIATION 37.6

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	10 / 10
serious Total, serious adverse events	0 / 10