Brain Activation in Response to Appetitive Cues Pre- and Post- Bariatric Surgery

Study Overview
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Brief Summary
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Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain activation in response to highly palatable (high energy density [kcal/g]), less palatable and non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing bariatric surgery (in surgery patients) and at equivalent times for control groups in fed and fasted conditions at each time point. Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month formula weight loss program or (ii) those who qualify, but do not undergo bariatric surgery, and receive no weight loss treatment.

Official Title
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Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Fed Condition
* Procedure: Fasted Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 and < 65 years BMI > 40 and < 50kg/m2 Right handed Good comprehension of English Exclusion Criteria: > 5% weight fluctuation in the past 3 months Presence of disease (including diabetes) Pregnancy, lactation or planning to become pregnant in next 18mon Smoking, or or recent (within past 12 month) smoking cessation Consumption of > 3 alcoholic beverages per day Left handed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roux-En Y Gastric Bypass<br>40 subjects who plan to undergo Roux-En-Y Gastric Bypass bariatric surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery. | Procedure: Fed Condition<br>* Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.<br>Procedure: Fasted Condition<br>* Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues<br>|
| Experimental: Gastric Banding<br>40 Subjects who plan to undergo Gastric Banding bariatric Surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery. | Procedure: Fed Condition<br>* Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.<br>Procedure: Fasted Condition<br>* Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues<br>|
| Experimental: Formula Diet Weight-Loss<br>40 subjects will undertake a 12-week liquid formula weight loss plan. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition pre-weight loss and 3 months after a 12-week weight loss plan. | Procedure: Fed Condition<br>* Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.<br>Procedure: Fasted Condition<br>* Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues<br>|
| Experimental: No Treatment<br>40 subjects who do not undergo any treatment for weight loss. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition at baseline and after 3 months. | Procedure: Fed Condition<br>* Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.<br>Procedure: Fasted Condition<br>* Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD signal response to visual and auditory food cues | BOLD signal changes in the brain in response to highly palatable (high energy density [kcal/g]), less palatable (low energy density)and non-food, stimuli in severely obese women pre-surgery, 1 month post-surgery and 3 months post bariatric surgery | pre-surgery, 1mo post and 3mo post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-en-Y Bariatric surgery,, Gastric banding,, fMRI,, food cues