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Clinical Trials/NCT01590914
NCT01590914
Completed
Not Applicable

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

New York Obesity and Nutrition Research Center2 sites in 1 country120 target enrollmentJanuary 2008
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
New York Obesity and Nutrition Research Center
Enrollment
120
Locations
2
Primary Endpoint
BOLD signal response to visual and auditory food cues
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
January 2014
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
New York Obesity and Nutrition Research Center
Responsible Party
Principal Investigator
Principal Investigator

Dr. Allan Geliebter

Principal Investigator

New York Obesity and Nutrition Research Center

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (2)

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