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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Procedure: Fed Condition; Procedure: Fasted Condition

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10025
      • St Luke's Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Roux-En Y Gastric Bypass; 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; 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.; Procedure: Fasted Condition; 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
EXPERIMENTAL: Gastric Banding; 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; 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.; Procedure: Fasted Condition; 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
EXPERIMENTAL: Formula Diet Weight-Loss; 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; 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.; Procedure: Fasted Condition; 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
EXPERIMENTAL: No Treatment; 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; 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.; Procedure: Fasted Condition; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York Obesity and Nutrition Research Center
• Collaborators: Columbia University; St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Allan Geliebter, PhD, New York Nutrition & Obesity Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (ESTIMATE): May 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2013
• Last Update Submitted That Met QC Criteria: March 8, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Roux-en-Y Bariatric surgery,; Gastric banding,; fMRI,; food cues
• Other Study ID Numbers: 08-174