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

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ClinicalTrials.gov Identifier: NCT01590914
Recruitment Status : Unknown
Verified March 2013 by Dr. Allan Geliebter, New York Obesity and Nutrition Research Center.
Recruitment status was:  Enrolling by invitation
First Posted : May 3, 2012
Last Update Posted : March 11, 2013
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

Brief Summary:

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 or disease Intervention/treatment
Obesity Procedure: Fed Condition Procedure: Fasted Condition

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery
Study Start Date : January 2008
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. BOLD signal response to visual and auditory food cues [ Time Frame: pre-surgery, 1mo post and 3mo post surgery ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: March 2013

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