fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Columbia University
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01583725
First received: March 9, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery.

Obese persons between the ages of 18 & 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.


Condition Intervention
Obesity
Procedure: Liquid meal responses
Behavioral: fMRI responses to food-cues

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Brain Imaging and Appetite-Related Hormones Pre and Post Obesity Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in brain activation in response to visual and auditory food cues [ Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery ] [ Designated as safety issue: No ]
    Measures of brain brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). Over the course of 40-min fMRI scans, we will compare change in activation from 3 mo pre-surgery to 3 and 18 mo post-surgery, and predict a post-surgical decrease in activation in such regions.


Secondary Outcome Measures:
  • Anthropometrics and Body Composition [ Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery ] [ Designated as safety issue: No ]
    Height and weight will be assessed using a stadiometer and digital scale. Sagittal diameter and waist and hip circumferences, as well as maximum supine width, will be measured. Waist circumference will be measured. Air displacement (Bioelectrical impedance analyses) will also be performed to obtain lean and fat mass. Weights, BMI, and body composition will confirm that the four obese groups are similar at baseline and provide estimates of changes in body fat following treatment.

  • Mood Measures [ Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery ] [ Designated as safety issue: No ]

    We will administer relevant psychological instruments to assess Mood:

    The Inventory of Depressive Symptomatology-Self Report (IDS-SR)will be assessed at 3mo pre-surgery, 3mo, 6mo and 18mo post surgery.


  • Change in appetite-related gut peptide levels [ Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery ] [ Designated as safety issue: No ]
    We will measure changes in appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. This will be assessed via blood plasma samples taken on 3 occasions: 3 mo pre-surgery, 3 mo post-surgery, and 18 mo post-surgery. At each session, there will be multiple time points: -15, 0, 15, 30, 60, and 90 minutes before/after ingestion of a meal replacement shake.

  • Eating Behavior [ Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery ] [ Designated as safety issue: No ]
    We will administer relevant psychological instruments to assess Eating Behavior:including Eating Disorder Examination (EDE) to diagnose BED; Binge Eating Scale (BES), correlated with BED status; eating-related behavior (DEBQ - Restraint, Emotional, and Externality subscales); and dietary intake (24-Hour Food Recall).


Estimated Enrollment: 160
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roux-en-Y Gastric Bypass
30 subjects who plan to undergo Roux-en-Y Gastric Bypass bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Procedure: Liquid meal responses
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Other Name: Meal replacement shake is the product Glytrol.
Behavioral: fMRI responses to food-cues
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Other Name: Food cue responses
Experimental: Gastric Banding (Lap-band)
30 subjects who plan to undergo Gastric Banding bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Procedure: Liquid meal responses
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Other Name: Meal replacement shake is the product Glytrol.
Behavioral: fMRI responses to food-cues
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Other Name: Food cue responses
Experimental: Formula Diet Weight Loss
30 subjects who plan to begin a formula diet to lose weight. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before subjects undertake a 12-week weight loss intervention (T1), at the end of the weight loss intervention (T2) and 18 months after they completed the weight loss intervention(T3).
Procedure: Liquid meal responses
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Other Name: Meal replacement shake is the product Glytrol.
Behavioral: fMRI responses to food-cues
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Other Name: Food cue responses
Experimental: No Treatment
30 subjects who do not undergo any treatment for weight loss. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed at baseline (T1) and at 3 months (T2) and 18 months (T3) later.
Procedure: Liquid meal responses
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Other Name: Meal replacement shake is the product Glytrol.
Behavioral: fMRI responses to food-cues
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Other Name: Food cue responses
Experimental: Sleeve Gastrectomy Surgery
30 subjects who plan to undergo Sleeve Gastrectomy bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Procedure: Liquid meal responses
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
Other Name: Meal replacement shake is the product Glytrol.
Behavioral: fMRI responses to food-cues
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
Other Name: Food cue responses

Detailed Description:

Currently, the only effective long term treatment for severe obesity is bariatric surgery.2 Nearly 200,000 procedures are performed each year, with this number increasing rapidly.3 However, the mechanisms of reduced food intake and weight loss after obesity surgery, particularly Rouen-Y gastric bypass (RYGB), are not well understood. This study utilizes functional magnetic resonance imaging (fMRI) and measures of appetite-related gut peptide levels pre and post bariatric surgery to investigate the neurological and hormonal mechanisms involved in initiation and termination of meals.

The general objective is to better understand the physiological changes resulting in weight loss from obesity surgery, particularly Roux-en-Y gastric bypass (RYGB). The main hypothesis is that the differential mechanisms of action in RYGB will alter the signals involved in the initiation and termination of meals, reflected by changes in both peptide hormone levels and regional brain activity in response to foods. The investigators anticipate that the trigger for meal initiation by potent food stimuli will be diminished following RYGB, as indicated by reduced brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). RYGB will be compared to: a. Gastric Banding (GB), representing the restrictive component of surgery, which itself enhances fullness, but in the absence of any rerouting of the gut, should result in fewer changes in gut peptide levels and brain activation; b. Weight Loss (WL) on a formula diet over 3 mo, which represents the weight loss component of surgery; and c. No Treatment (NT), a general control, with no gastric restriction or weight loss. These group comparisons will help parse the contributions of RYGB surgery to weight loss.

The plan is to study clinically severe obese subjects (S's) pre surgery, and at 3 and 18 mo post surgery. The investigators will examine: 1) fMRI brain activation in response to food stimuli and 2) appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. The findings should reveal potential mechanisms associated with the changes in appetite, eating behaviors, and body weight, both during the rapid weight loss phase at 3 mo post surgery as well as when weight typically stabilizes at a nadir at 18 mo post surgery. The investigators plan to enroll 160 patients: 40 with RYGB, 40 GB, 40 WL, and 40 NT (4-arm study). S's will be within the BMI range of 40-50 and matched across groups for BMI, gender (3:1, f:m), and BED status.

  Eligibility

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

Inclusion Criteria:

  • BMI range 35-50 kg/m^2

Exclusion Criteria:

  • diabetes,
  • smoking,
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583725

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

Additional Information:
Publications:

Responsible Party: Dr. Allan Geliebter, Principal Investigator, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01583725     History of Changes
Other Study ID Numbers: 09-101
Study First Received: March 9, 2012
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York Obesity and Nutrition Research Center:
Obesity
Bariatric surgery
Weight loss
fMRI
gut peptides

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

ClinicalTrials.gov processed this record on September 18, 2014