PET Imaging and Bariatric Surgery

NCT ID: NCT00801827

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

F-18 (fallypride)

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.

Group Type: EXPERIMENTAL

F-18 (fallypride)

Intervention Type: DRUG

Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Julia P.Dunn,MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia P Dunn, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Robert M Kessler, MD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IRB#061246

Identifier Type: -

Identifier Source: org_study_id