PET Imaging and Bariatric Surgery
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
March 17, 2017
CompletedMarch 17, 2017
January 1, 2017
4.2 years
December 2, 2008
August 22, 2016
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
~7 weeks
Study Arms (1)
F-18 (fallypride)
EXPERIMENTALSubjects 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.
Interventions
Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Julia Dunn, MD
- Organization
- Vanderbilt_University
Study Officials
- PRINCIPAL INVESTIGATOR
Julia P Dunn, MD
Vanderbilt University Medical Center
- STUDY DIRECTOR
Robert M Kessler, MD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
January 1, 2007
Primary Completion
March 1, 2011
Study Completion
June 1, 2012
Last Updated
March 17, 2017
Results First Posted
March 17, 2017
Record last verified: 2017-01