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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
St. Luke's-Roosevelt Hospital Center
Columbia University
Information provided by (Responsible Party):
Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01590914
First received: May 1, 2012
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Procedure: Fed Condition
Procedure: Fasted Condition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York Obesity and Nutrition Research Center:

Primary Outcome Measures:
  • BOLD signal response to visual and auditory food cues [ Time Frame: pre-surgery, 1mo post and 3mo post surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590914

Locations
United States, New York
St Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York Obesity and Nutrition Research Center
St. Luke's-Roosevelt Hospital Center
Columbia University
Investigators
Principal Investigator: Allan Geliebter, PhD New York Nutrition & Obesity Research Center
  More Information

No publications provided

Responsible Party: Dr. Allan Geliebter, Principal Investigator, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01590914     History of Changes
Other Study ID Numbers: 08-174
Study First Received: May 1, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York Obesity and Nutrition Research Center:
Roux-en-Y Bariatric surgery,
Gastric banding,
fMRI,
food cues

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013