Back to resultsPET Imaging and Bariatric Surgery
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
F-18 (fallypride)
Sponsored by
About this trial
This is an interventional basic science trial for Obesity, Morbid focused on measuring Obesity, Addiction, PET imaging
Eligibility Criteria
Inclusion Criteria:
- Ages 18-60 years
- BMI equal to or greater than 40, or equal to or greater than 35 if there are 2 or more co-morbidities
- Weight less than 350 pounds
Exclusion Criteria:
- History of substance abuse,including but not limited to alcohol, cocaine, marijuana, heroin, nicotine
- History of psychiatric disorders
- Use of any antidepressants or psychotropics in the past 12 months
- Diabetes Mellitis
- Positive pregnancy test
- Any condition felt by the PI or co-investigators to interfere with the individual's ability to complete the study
- Subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the PI
- Inability to travel to Nashville, TN four times
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F-18 (fallypride)
Arm Description
Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2/3 (DA D2/3) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
Outcomes
Primary Outcome Measures
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT00801827
First Posted
December 2, 2008
Last Updated
January 27, 2017
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00801827
Brief Title
PET Imaging and Bariatric Surgery
Official Title
PET Imaging and Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.
Detailed Description
The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Obesity, Addiction, PET imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F-18 (fallypride)
Arm Type
Experimental
Arm Description
Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2/3 (DA D2/3) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
Intervention Type
Drug
Intervention Name(s)
F-18 (fallypride)
Intervention Description
Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.
Primary Outcome Measure Information:
Title
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
Time Frame
~7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-60 years
BMI equal to or greater than 40, or equal to or greater than 35 if there are 2 or more co-morbidities
Weight less than 350 pounds
Exclusion Criteria:
History of substance abuse,including but not limited to alcohol, cocaine, marijuana, heroin, nicotine
History of psychiatric disorders
Use of any antidepressants or psychotropics in the past 12 months
Diabetes Mellitis
Positive pregnancy test
Any condition felt by the PI or co-investigators to interfere with the individual's ability to complete the study
Subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the PI
Inability to travel to Nashville, TN four times
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia P Dunn, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert M Kessler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PET Imaging and Bariatric Surgery
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