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Trial record 5 of 5 for:    "Hypothalamic Obesity" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

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

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ClinicalTrials.gov Identifier: NCT01484873
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : August 11, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Ashley Shoemaker, Vanderbilt University Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obesity
Overweight
Craniopharyngioma
Intervention Drug: Exenatide
Enrollment 10
Recruitment Details University clinics and online advertisements from June, 2012 - March, 2013
Pre-assignment Details  
Arm/Group Title Exenatide
Hide Arm/Group Description exenatide 10 mcg twice daily
Period Title: Overall Study
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Exenatide
Hide Arm/Group Description exenatide 10 mcg twice daily
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
2
  20.0%
Between 18 and 65 years
8
  80.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
1
  10.0%
Not Hispanic or Latino
9
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants
137.2  (37.6)
Resting energy expenditure  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 10 participants
2215.0  (654.9)
Satiety   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 10 participants
68.9  (15.4)
[1]
Measure Description: minimum 0, maximum 100
Insulin AUC  
Mean (Standard Deviation)
Unit of measure:  120 min*uU/mL
Number Analyzed 10 participants
13076  (7482)
Gastric emptying half life  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 10 participants
175.4  (81.0)
1.Primary Outcome
Title Body Weight (kg)
Hide Description Change in body weight from baseline to end of study
Time Frame baseline, 50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the study
Arm/Group Title Exenatide
Hide Arm/Group Description:
exenatide 10 mcg twice daily
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: kg
-1.4
(-2.2 to 4.9)
2.Secondary Outcome
Title Resting Energy Expenditure (Kcals Per Day)
Hide Description Change in resting energy expenditure from baseline to 50 weeks
Time Frame baseline, 50 weeks
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
exenatide 10 mcg twice daily
Overall Number of Participants Analyzed 7
Mean (95% Confidence Interval)
Unit of Measure: kcal/day
-157.7
(-766.1 to 450.6)
3.Secondary Outcome
Title Visual Analogue Scales for Post-meal Satiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide
Hide Arm/Group Description:
Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: mm
-2.5
(-19.7 to 14.7)
4.Secondary Outcome
Title Insulin Secretion (Area Under the Curve)
Hide Description Change in insulin secretion from baseline
Time Frame baseline, 50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide
Hide Arm/Group Description:
exenatide 10 mcg twice daily
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: 120 min*uU/mL x
-89.3
(-5127 to 4948)
5.Secondary Outcome
Title Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)
Hide Description Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks
Time Frame baseline, 50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide
Hide Arm/Group Description:
exenatide 10 mcg twice daily
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: minutes
12.9
(-38.5 to 64.3)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide
Hide Arm/Group Description exenatide 10 mcg twice daily
All-Cause Mortality
Exenatide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exenatide
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Nose bleed   1/10 (10.00%)  1
Cardiac disorders   
Irregular heart beat   1/10 (10.00%)  1
Ear and labyrinth disorders   
Acute otitis media   1/10 (10.00%)  1
Endocrine disorders   
Hypoglycemia   2/10 (20.00%)  2
Gastrointestinal disorders   
Nausea   7/10 (70.00%)  7
Vomiting   2/10 (20.00%)  2
Gastroenteritis   3/10 (30.00%)  3
General disorders   
Fatigue   1/10 (10.00%)  1
Infections and infestations   
URI   3/10 (30.00%)  4
strep throat   1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Myalgias   1/10 (10.00%)  1
Joint pain   3/10 (30.00%)  3
Nervous system disorders   
Headache   1/10 (10.00%)  1
tingling/numbness   1/10 (10.00%)  1
Psychiatric disorders   
Mood swings   1/10 (10.00%)  1
Anxiety   1/10 (10.00%)  1
Renal and urinary disorders   
kidney stones   1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Hives   1/10 (10.00%)  1
Injection site reaction   2/10 (20.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ashley Shoemaker
Organization: Vanderbilt University
Phone: 615-343-8116
Responsible Party: Ashley Shoemaker, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01484873     History of Changes
Other Study ID Numbers: 111185
First Submitted: October 20, 2011
First Posted: December 2, 2011
Results First Submitted: February 9, 2016
Results First Posted: August 11, 2016
Last Update Posted: March 3, 2017