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

May 1, 2012
March 8, 2013
January 2008
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01590914 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
  • 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: 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.
    Interventions:
    • Procedure: Fed Condition
    • Procedure: Fasted Condition
  • 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.
    Interventions:
    • Procedure: Fed Condition
    • Procedure: Fasted Condition
  • 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.
    Interventions:
    • Procedure: Fed Condition
    • Procedure: Fasted Condition
  • 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.
    Interventions:
    • Procedure: Fed Condition
    • Procedure: Fasted Condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01590914
08-174
No
Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
New York Obesity and Nutrition Research Center
  • St. Luke's-Roosevelt Hospital Center
  • Columbia University
Principal Investigator: Allan Geliebter, PhD New York Nutrition & Obesity Research Center
New York Obesity and Nutrition Research Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP