Functional MRI Evaluation of Brain Response to Visual Food Stimulation in Morbidly Obese Patients Before and After Bariatric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01140711
First received: June 8, 2010
Last updated: February 27, 2011
Last verified: February 2011
  Purpose

Aim of study:

To evaluate changes in feeding-related neural activity after different bariatric procedures in morbidly obese patients. Relationship of gut hormone levels will be assessed as well.


Condition Intervention
Morbid Obesity
Satiety
Procedure: fMRI imaging following visual stimulation of food and non-food images

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Change in neuronal activity response to visual food stimuli after bariatric surgery [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in circulating blood incretin levels after bariatric surgery [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Difference in measured parameters between sleeve gastrectomy and gastric bypass [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastric bypass
Patients submitted to gastric bypass for treatment of morbid obesity
Procedure: fMRI imaging following visual stimulation of food and non-food images

fMRI Scans will be performed in a 3 tesla MRI scanner. All subjects will be scanned for anatomical imaging without injection of contrast material. These structural images will be used to localize the functional data obtained. Functional test will include several measurements of brain activity while viewing visual stimuli.

fMRI allows collection of information about brain activity with good spatial and temporal resolution. Protocols allow rapid assessment of regional activation in different brain regions during exposure to different visual stimuli.It provides a detailed functional map.

Scan test protocol includes anatomical measurement - 3D FSPGE T1w sequence, Asset DTI and repeated fMRI measurements (based on echo EPI, T2 * w, BOLD sequences). Test paradigms include picture collections of various foods non-food objects similar in size, color and shape.

Experimental: Sleeve gastrectomy
Patients submitted to sleeve gastrectomy for treatment of morbid obesity
Procedure: fMRI imaging following visual stimulation of food and non-food images

fMRI Scans will be performed in a 3 tesla MRI scanner. All subjects will be scanned for anatomical imaging without injection of contrast material. These structural images will be used to localize the functional data obtained. Functional test will include several measurements of brain activity while viewing visual stimuli.

fMRI allows collection of information about brain activity with good spatial and temporal resolution. Protocols allow rapid assessment of regional activation in different brain regions during exposure to different visual stimuli.It provides a detailed functional map.

Scan test protocol includes anatomical measurement - 3D FSPGE T1w sequence, Asset DTI and repeated fMRI measurements (based on echo EPI, T2 * w, BOLD sequences). Test paradigms include picture collections of various foods non-food objects similar in size, color and shape.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Morbidly obese
  2. Having passed standard preoperative, multidisciplinary evaluation and deemed acceptable for surgery

Exclusion Criteria:

  1. Claustrophobic
  2. Having other cotnraindication for MRI testing (metalic implants, etc.)
  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: NCT01140711

Contacts
Contact: David Goitein, MD +97235302714 david.goitein@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: David Goitein, MD    +97235302714    david.goitein@sheba.health.gov.il   
Principal Investigator: David Goitein, MD         
Sub-Investigator: Gabriella Lieberman, MD         
Sponsors and Collaborators
Sheba Medical Center