PET Imaging and Bariatric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00801827
First received: December 2, 2008
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Obesity, Morbid
Drug: F-18 (fallypride)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PET Imaging and Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • DRD2 density changes after bariatric surgery [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DRD2 density will change after very low calorie diet [ Time Frame: 9-11 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma and serum


Estimated Enrollment: 10
Study Start Date: January 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

BMI greater than 35, ages 18-60, pending weight loss surgery

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801827

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Julia P Dunn, MD Vanderbilt University
Study Director: Robert M Kessler, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Julia Dunn, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00801827     History of Changes
Other Study ID Numbers: IRB#061246
Study First Received: December 2, 2008
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Obesity
Addiction
PET imaging

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014