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

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:

MedlinePlus related topics: Obesity Weight Loss Surgery

U.S. FDA Resources

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.

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:

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

Exclusion Criteria:

Claustrophobic
Having other cotnraindication for MRI testing (metalic implants, etc.)

Contacts and Locations

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

More Information

Publications:

Führer D, Zysset S, Stumvoll M. Brain activity in hunger and satiety: an exploratory visually stimulated FMRI study. Obesity (Silver Spring). 2008 May;16(5):945-50. Epub 2008 Feb 21.

Stice E, Spoor S, Bohon C, Veldhuizen MG, Small DM. Relation of reward from food intake and anticipated food intake to obesity: a functional magnetic resonance imaging study. J Abnorm Psychol. 2008 Nov;117(4):924-35.

Cummings DE, Weigle DS, Frayo RS, Breen PA, Ma MK, Dellinger EP, Purnell JQ. Plasma ghrelin levels after diet-induced weight loss or gastric bypass surgery. N Engl J Med. 2002 May 23;346(21):1623-30.

le Roux CW, Welbourn R, Werling M, Osborne A, Kokkinos A, Laurenius A, Lönroth H, Fändriks L, Ghatei MA, Bloom SR, Olbers T. Gut hormones as mediators of appetite and weight loss after Roux-en-Y gastric bypass. Ann Surg. 2007 Nov;246(5):780-5.

Responsible Party:	David Goitein, Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01140711 History of Changes
Other Study ID Numbers:	SHEBA-7649-10-DG-CTIL
Study First Received:	June 8, 2010
Last Updated:	February 27, 2011
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013