A Phase 1 interventional study of F-18 (fallypride) in Obesity, Morbid, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-03-17.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Basic science
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.
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 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.
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
Time frame: ~7 weeks
| Milestone | Surgical |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| percentage of binding potential change | F-18 (Fallypride) |
|---|---|
| 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 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| F-18 (Fallypride) | — | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Surgical |
|---|---|
| Mean | 45.8 ± 4.27 |
| Sex: Female, Male(Participants) | Surgical |
|---|---|
| Female | 5 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Surgical |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Surgical |
|---|---|
| United States | 5 |
| Preop BMI(kg/m^2) | Surgical |
|---|---|
| Mean | 43.2 ± 6.26 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center