Obesity, Morbid Clinical Trial
Official title:
PET Imaging and Bariatric Surgery
Verified date | March 2011 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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) and other studies have shown that obese people have less of these. We propose that low DRD2 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DRD2 density changes after bariatric surgery | 6-12 weeks | No | |
Secondary | DRD2 density will change after very low calorie diet | 9-11 days | No |
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