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Clinical Trials/NCT01140711
NCT01140711CompletedNot Applicable

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

Sheba Medical Center2 sites in 1 country30 target enrollmentStarted: January 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Change in neuronal activity response to visual food stimuli after bariatric surgery

Study Overview

Brief Summary

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.

Detailed Description

Bariatric surgery mediates weight-loss via one or several mechanisms inherent to each technique used. Surgical restriction is the "lowest common denominator" shared, to various extent, by all procedures. Different degrees of malabsorption are utilized in "bypass procedures" such as Roux-Y gastric bypass (GBP), biliopancreatic diversion (BPD) and biliopancreatic diversion with duodenal switch (BPD-DS). These surgical options differ, also, in the degree of weight loss they promote. This difference is due to several factors including the extent of appetite suppression, increase in energy expenditure and degree of malabsorption achieved by the different procedures.

A post-operative change in the gut-brain hormonal axis is a component that has recently drawn much attention and research but is still ill defined. It is an effect, presumably mediated by a change in a myriad of peptides and hormones originating mostly from the intestinal tract, eliciting a change in hunger and satiety feelings as well as a change in the drive to eat. Generally speaking, patients after sleeve gastrectomy (SG) and the bypass procedures mentioned, have a decreased appetite and report a reduced drive to seek food, which presumably contributes to their weight loss.

Functional magnetic resonance imaging (fMRI) is an imaging modality which measures the hemodynamic response (change in blood flow) related to neural activity in the brain, therefore allowing mapping of areas in the brain which become active due to discrete stimuli.

Recent studies utilizing fMRI to study neural response to hunger and satiety states, as well as to food anticipation and ingestion, have mapped discrete areas in the brain which respond to these stimuli. Fuhrer and colleagues found that during hunger, significantly enhanced brain activity is found in the left striate and extrastriate cortex, the inferior parietal lobe, and the orbitofrontal cortices. Stimulation with food images was associated with increased activity in both insulae, the left striate and extrastriate cortex, and the anterior midprefrontal cortex. Nonfood images were associated with enhanced activity in the right parietal lobe and the left and right middle temporal gyrus1. Stice and colleagues reported brain imaging studies which suggested that obese relative to lean individuals show greater activation of the gustatory cortex (insula/frontal operculum) and oral somatosensory regions (parietal operculum and Rolandic operculum) in response to anticipated intake and consumption of palatable foods.

Ghrelin is an orexigenic (appetite stimulating) peptide secreted by the foregut prior to meals and is therefore considered a "meal initiator". Obese patients have low ghrelin levels but maintain a normal diurnal variation of this peptide, while patients after GBP, have reduced ghrelin levels which remain low throughout the day 3. Malik and co-workers demonstrated that when ghrelin was administered intravenously to healthy volunteers during fMRI the neural response to food pictures was affected. The neural effects of ghrelin were correlated with self-rated hunger ratings.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.)

Arms & Interventions

Gastric bypass

Experimental

Patients submitted to gastric bypass for treatment of morbid obesity

Intervention: fMRI imaging following visual stimulation of food and non-food images (Procedure)

Sleeve gastrectomy

Experimental

Patients submitted to sleeve gastrectomy for treatment of morbid obesity

Intervention: fMRI imaging following visual stimulation of food and non-food images (Procedure)

Outcomes

Primary Outcomes

Change in neuronal activity response to visual food stimuli after bariatric surgery

Time Frame: Baseline and 6 months

Secondary Outcomes

  • Change in circulating blood incretin levels after bariatric surgery(Baseline and 6 months)
  • Difference in measured parameters between sleeve gastrectomy and gastric bypass(Baseline and 6 months)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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