Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exenatide All patients received exenatide 10mcg BID x 50 weeks |
Drug: Exenatide
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Body Weight (kg) [baseline, 50 weeks]
Change in body weight from baseline to end of study
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Ashley Shoemaker, M.D., Vanderbilt University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 111185
Study Results
Participant Flow
| Recruitment Details | University clinics and online advertisements from June, 2012 - March, 2013 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | exenatide 10 mcg twice daily |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 8 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | exenatide 10 mcg twice daily |
| Overall Participants | 10 |
| Age (Count of Participants) | |
| <=18 years |
2
20%
|
| Between 18 and 65 years |
8
80%
|
| >=65 years |
0
0%
|
| Gender (Count of Participants) | |
| Female |
7
70%
|
| Male |
3
30%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
10%
|
| Not Hispanic or Latino |
9
90%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
10
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
10
100%
|
| Weight (kg) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg] |
137.2
(37.6)
|
| Resting energy expenditure (kcal/day) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kcal/day] |
2215.0
(654.9)
|
| Satiety (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
68.9
(15.4)
|
| Insulin AUC (120 min*uU/mL) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [120 min*uU/mL] |
13076
(7482)
|
| Gastric emptying half life (minutes) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [minutes] |
175.4
(81.0)
|
Outcome Measures
| Title | Body Weight (kg) |
|---|---|
| Description | Change in body weight from baseline to end of study |
| Time Frame | baseline, 50 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients that completed the study |
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | exenatide 10 mcg twice daily |
| Measure Participants | 8 |
| Mean (95% Confidence Interval) [kg] |
-1.4
|
| Title | Resting Energy Expenditure (Kcals Per Day) |
|---|---|
| Description | Change in resting energy expenditure from baseline to 50 weeks |
| Time Frame | baseline, 50 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 8 patients completed the study but one patient did not have REE data available due to technical difficulties |
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | exenatide 10 mcg twice daily |
| Measure Participants | 7 |
| Mean (95% Confidence Interval) [kcal/day] |
-157.7
|
| Title | Visual Analogue Scales for Post-meal Satiety |
|---|---|
| Description | Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100). |
| Time Frame | baseline, 50 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks. |
| Measure Participants | 8 |
| Mean (95% Confidence Interval) [mm] |
-2.5
|
| Title | Insulin Secretion (Area Under the Curve) |
|---|---|
| Description | Change in insulin secretion from baseline |
| Time Frame | baseline, 50 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | exenatide 10 mcg twice daily |
| Measure Participants | 8 |
| Mean (95% Confidence Interval) [120 min*uU/mL x] |
-89.3
|
| Title | Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life) |
|---|---|
| Description | Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks |
| Time Frame | baseline, 50 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Exenatide |
|---|---|
| Arm/Group Description | exenatide 10 mcg twice daily |
| Measure Participants | 8 |
| Mean (95% Confidence Interval) [minutes] |
12.9
|
Adverse Events
| Time Frame | 1 year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Exenatide | |
| Arm/Group Description | exenatide 10 mcg twice daily | |
All Cause Mortality |
||
| Exenatide | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Exenatide | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Exenatide | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/10 (100%) | |
| Blood and lymphatic system disorders | ||
| Nose bleed | 1/10 (10%) | 1 |
| Cardiac disorders | ||
| Irregular heart beat | 1/10 (10%) | 1 |
| Ear and labyrinth disorders | ||
| Acute otitis media | 1/10 (10%) | 1 |
| Endocrine disorders | ||
| Hypoglycemia | 2/10 (20%) | 2 |
| Gastrointestinal disorders | ||
| Nausea | 7/10 (70%) | 7 |
| Vomiting | 2/10 (20%) | 2 |
| Gastroenteritis | 3/10 (30%) | 3 |
| General disorders | ||
| Fatigue | 1/10 (10%) | 1 |
| Infections and infestations | ||
| URI | 3/10 (30%) | 4 |
| strep throat | 1/10 (10%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Myalgias | 1/10 (10%) | 1 |
| Joint pain | 3/10 (30%) | 3 |
| Nervous system disorders | ||
| Headache | 1/10 (10%) | 1 |
| tingling/numbness | 1/10 (10%) | 1 |
| Psychiatric disorders | ||
| Mood swings | 1/10 (10%) | 1 |
| Anxiety | 1/10 (10%) | 1 |
| Renal and urinary disorders | ||
| kidney stones | 1/10 (10%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Hives | 1/10 (10%) | 1 |
| Injection site reaction | 2/10 (20%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ashley Shoemaker |
|---|---|
| Organization | Vanderbilt University |
| Phone | 615-343-8116 |
| ashley.h.shoemaker@vanderbilt.edu |
- 111185