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PET Imaging and Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00801827
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Julia P.Dunn,MD, Vanderbilt University Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Obesity, Morbid
Intervention Drug: F-18 (fallypride)
Enrollment 7
Recruitment Details  
Pre-assignment Details 7 patients consented to the study but 2 never participated due to scheduling conflicts. All 5 participants that started the study went on to complete the study.
Arm/Group Title Surgical
Hide Arm/Group Description Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
Period Title: Overall Study
Started 5 [1]
Completed 5
Not Completed 0
[1]
2 others consented but due to scheduling did not complete
Arm/Group Title Surgical
Hide Arm/Group Description Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
45.8  (4.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 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
1
  20.0%
White
4
  80.0%
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 5 participants
5
Preop BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 5 participants
43.2  (6.26)
1.Primary Outcome
Title Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
Hide Description [Not Specified]
Time Frame ~7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 (Fallypride)
Hide Arm/Group Description:
Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percentage of binding potential change
Caudate -10.14  (2.74)
Putamen -9.39  (6.67)
Ventral Striatum -8.11  (3.90)
Hypothalamus -8.76  (2.52)
Substania nigra -10.2  (1.78)
Medial thalamus -8.17  (2.10)
Amygdala -8.99  (2.52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title F-18 (Fallypride)
Hide Arm/Group Description

Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.

F-18 (fallypride): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.

All-Cause Mortality
F-18 (Fallypride)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
F-18 (Fallypride)
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
F-18 (Fallypride)
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julia Dunn, MD
Organization: Vanderbilt_University
Phone: 615-343-8389
EMail: julia.dunn@va.gov
Layout table for additonal information
Responsible Party: Julia P.Dunn,MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00801827     History of Changes
Other Study ID Numbers: IRB#061246
First Submitted: December 2, 2008
First Posted: December 4, 2008
Results First Submitted: August 22, 2016
Results First Posted: March 17, 2017
Last Update Posted: March 17, 2017