Obesity, Morbid
Conditions
Keywords
Obesity, Addiction, PET imaging
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.
Interventions
DRUGF-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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | ~7 weeks |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Surgical Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Surgical |
|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 4.27 |
| Preop BMI | 43.2 kg/m^2 STANDARD_DEVIATION 6.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
Time frame: ~7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Caudate | -10.14 percentage of binding potential change | Standard Deviation 2.74 |
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Putamen | -9.39 percentage of binding potential change | Standard Deviation 6.67 |
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Ventral Striatum | -8.11 percentage of binding potential change | Standard Deviation 3.9 |
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Hypothalamus | -8.76 percentage of binding potential change | Standard Deviation 2.52 |
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Substania nigra | -10.2 percentage of binding potential change | Standard Deviation 1.78 |
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Medial thalamus | -8.17 percentage of binding potential change | Standard Deviation 2.1 |
| F-18 (Fallypride) | Regional DRD2/3 Binding Percent Changes After Bariatric Surgery | Amygdala | -8.99 percentage of binding potential change | Standard Deviation 2.52 |