Trial Outcomes & Findings for PET Imaging and Bariatric Surgery (NCT NCT00801827)

NCT ID: NCT00801827

Last Updated: 2017-03-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: ~7 weeks
• Results posted on: 2017-03-17

Participant Flow

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.

Participant milestones

Measure	Surgical Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET Imaging and Bariatric Surgery

Baseline characteristics by cohort

Measure	Surgical n=5 Participants Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
Age, Continuous	45.8 years STANDARD_DEVIATION 4.27 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Preop BMI	43.2 kg/m^2 STANDARD_DEVIATION 6.26 • n=5 Participants

PRIMARY outcome

Timeframe: ~7 weeks

Outcome measures

Measure	F-18 (Fallypride) n=5 Participants 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.
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Caudate	-10.14 percentage of binding potential change Standard Deviation 2.74
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Putamen	-9.39 percentage of binding potential change Standard Deviation 6.67
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Ventral Striatum	-8.11 percentage of binding potential change Standard Deviation 3.90
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Hypothalamus	-8.76 percentage of binding potential change Standard Deviation 2.52
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Substania nigra	-10.2 percentage of binding potential change Standard Deviation 1.78
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Medial thalamus	-8.17 percentage of binding potential change Standard Deviation 2.10
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery Amygdala	-8.99 percentage of binding potential change Standard Deviation 2.52

Adverse Events

F-18 (Fallypride)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia Dunn, MD

Vanderbilt_University

Phone: 615-343-8389

Email: julia.dunn@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place