PET Imaging and Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title:

PET Imaging and Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801827
• Other study ID #: IRB#061246
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: December 12, 2015
• Start date: January 2007
• Est. completion date: June 2012

Study information

• 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

Clinical Trial 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) 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

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