Status:

COMPLETED

Neural Response to Eating and Weight Status

Lead Sponsor:

University of Pennsylvania

Conditions:

Obesity

Eligibility:

FEMALE

18+ years

Brief Summary

This study will compare brain and hormone responses to food images (and food) in women who undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic adjustable gastric ban...

Detailed Description

We hypothesize that RYGB-treated patients will exhibit greater reductions (from baseline) in BOLD response in areas associated with homeostatic and hedonic eating than will both LAGB/LSG and control p...

Eligibility Criteria

Inclusion

  • Women
  • Over 18 years old
  • BMI of 40 kg/ m2 (or 35 kg/m2 in the presence of significant weight-related comorbidities, including established coronary artery disease, established peripheral arterial disease, symptomatic carotid artery disease, sleep apnea, metabolic syndrome, cardiomyopathy, hypertension, and debilitating joint pain).
  • Non-surgical group must be willing to remain weight stable and not seek weight loss (i.e., defined as remaining within 5% of baseline weight).

Exclusion

  • Weight \> 350 pounds the maximum weight that can be accommodated in the scanner); supine abdominal width (with arms folded above) \> 60 cm or sagittal diameter \> 50 cm (i.e., these are the maximum dimensions that can be accommodated in the scanner)
  • Pregnancy or lactation
  • Type 1 or type 2 diabetes
  • Severe major depression or other psychiatric disorder that significantly interferes with daily living
  • Substance use disorder (current or in remission 1 year)
  • Current use of nicotine or any illicit drug
  • Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
  • Use of weight loss medications or other agents known to affect body weight or blood glucose (e.g., glucocorticoids, second-generation antipsychotic medications)
  • Lack of capacity to provide informed consent
  • Non-surgical participants interested in losing weight in the next 2 years
  • Plans to relocate from the area within 2 years
  • Principal Investigator discretion

Key Trial Info

Start Date :

April 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT01228097

Start Date

April 1 2010

End Date

January 1 2015

Last Update

March 10 2015

Active Locations (1)

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1

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States, 19104