fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery

January 10, 2014 updated by: Dr. Allan Geliebter, New York Obesity and Nutrition Research Center

Functional Brain Imaging and Appetite-Related Hormones Pre and Post Obesity Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's-Roosevelt Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI range 35-50 kg/m^2

Exclusion Criteria:

  • diabetes,
  • smoking,
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Food cue responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
3 mo pre-surgery and 3 and 18 mo post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometrics and Body Composition
Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery
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.
3 mo pre-surgery and 3 and 18 mo post-surgery
Mood Measures
Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery

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.
3 mo pre-surgery and 3 and 18 mo post-surgery
Change in appetite-related gut peptide levels
Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery
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.
3 mo pre-surgery and 3 and 18 mo post-surgery
Eating Behavior
Time Frame: 3 mo pre-surgery and 3 and 18 mo post-surgery
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).
3 mo pre-surgery and 3 and 18 mo post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Obesity and Nutrition Research Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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