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PET Imaging and Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT00801827
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Julia P.Dunn,MD, Vanderbilt University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Drug: F-18 (fallypride) Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PET Imaging and Bariatric Surgery
Study Start Date : January 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Regional DRD2/3 Binding Percent Changes After Bariatric Surgery [ Time Frame: ~7 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801827


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Julia P Dunn, MD Vanderbilt University Medical Center
Study Director: Robert M Kessler, MD Vanderbilt University Medical Center
More Information
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Responsible Party: Julia P.Dunn,MD, Physician, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00801827    
Other Study ID Numbers: IRB#061246
First Posted: December 4, 2008    Key Record Dates
Results First Posted: March 17, 2017
Last Update Posted: March 17, 2017
Last Verified: January 2017
Keywords provided by Julia P.Dunn,MD, Vanderbilt University Medical Center:
Obesity
Addiction
PET imaging
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Fallypride
 Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs