Roux-en-Y Gastric Bypass and Weight Regain

April 5, 2018 updated by: Washington University School of Medicine

Characteristics Associated With Weight Regain After Roux-en-Y Gastric Bypass

This study compares eating behaviors, meal size, and the size of the gastric pouch and connection between the gastric pouch and small intestine in patients who had gastric bypass surgery two or more years ago and regained weight compared with patients who had gastric bypass surgery two or more years ago and maintained their weight loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity affects a third of adults in the United States. The most effective treatment for weight loss is bariatric surgery, and the most common surgery performed in the US is Roux-en-Y Gastric Bypass (RYGB). However, a significant number of patients regain weight that was lost after surgery. The mechanisms for weight regain are likely multifactorial, but not well understood. Disordered eating behaviors and dilated gastrojejunostomies (GJ), which presumably allows a patient to consume larger portion sizes during a meal, correlate with weight regain. Moreover, some data suggest that changes to the gut anatomy may drive eating behaviors and food preferences. However, no studies have simultaneously evaluated functional gastric volume (the volume of solid or liquid food that can be consumed to a level of comfortable fullness in one sitting), anatomical gastric pouch size and GJ diameter, and eating behaviors in patients who maintained their post RYGB weight compared with patients who have regained weight from their maximum weight loss after RYGB to determine the relationship among post RYGB eating behavior, functional and anatomical gastric pouch size, GJ diameter and weight change. Accordingly, the objectives of this proposal are to compare 1) eating behaviors 2) functional gastric volume and 3) anatomical dimensions of the gastric pouch and GJ in patients who are >2 years post RYGB and have regained >20% of their maximum lost weight and those who are >2 years post RYGB and have maintained at least 90% weight loss since surgery. The following specific aims will be evaluated:

Aim 1. Evaluate whether differences in eating behaviors exist between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that subjects who have regained weight after RYGB will have higher scores on binge eating behaviors and an increased craving for sweets compared with patients who have maintained weight loss after RYGB. Eating behaviors will be determined by performing the Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), and the National Cancer Institute (NCI) ASA24.

Aim 2. Evaluate whether differences exist in functional gastric volume between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that patients who have regained weight after RYGB will have an increased functional gastric volume to both solids and liquids compared to subjects who have maintained weight loss after RYGB. Functional gastric volume will be measured during both a solid and liquid meal test.

Aim 3. Evaluate whether differences exist in gastric pouch and GJ sizes between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that patients who have regained weight after RYGB will have increased gastric pouch size and GJ diameter compared with patients who have maintained their weight loss after RYGB. Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.

Study Type

Observational

Enrollment (Actual)

2

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
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 20 patients who had laparoscopic RYGB surgery >2 years before screening and have regained >20% weight from their maximum weight lost after surgery and 20 patients who had laparoscopic RYGB surgery >2 years before screening and have maintained at least 90% weight loss from the maximum weight loss after surgery. These patients will be identified from the bariatric surgical population at Washington University School of Medicine.

Description

Inclusion Criteria:

  • Ages of 21 and 60
  • Laparoscopic RYGB surgery >2 years before screening
  • Regained >20% weight from their maximum weight lost after surgery or maintained at least 90% weight loss from the maximum weight loss after surgery

Exclusion Criteria:

  • Allergy to lidocaine, nut allergies, milk intolerance or any other food allergies/restrictions that are included in our test meals
  • A history of alcohol abuse
  • Currently consuming >20 gm of alcohol per day
  • Greater than 2 points on the MAST
  • Severe organ dysfunction
  • Anemia (hemoglobin <10mg/dl)
  • PT, PTT and INR > 1.5x UNL
  • Triglycerides > 400
  • LFT > 2x UNL
  • Women who are pregnant or lactating
  • Participants that smoke greater than 20 pack years
  • Actively using illegal drugs
  • Depression or other psychological disorders that are untreated
  • Diabetics receiving Insulin
  • Patients that have been hospitalized and/or had surgery in the last three months that may be unstable (PI will determine this at Physical Exam)

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wt maintenance
Eating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes
Behavioral: Eating Behavior Evaluation
Scores will be measured on binge eating behaviors and an increased craving for sweets.
Other Names:
  • Yale Food Addiction Scale (YFAS)
  • Eating Disorder Examination (EDE)
  • The Food Craving Inventory (FCI)
  • National Cancer Institute (NCI) ASA24
Other: Measurement of Functional gastric volume
The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.
Other: Measurement of gastric pouch and GJ size
Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
Wt Regain
Eating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes
Behavioral: Eating Behavior Evaluation
Scores will be measured on binge eating behaviors and an increased craving for sweets.
Other Names:
  • Yale Food Addiction Scale (YFAS)
  • Eating Disorder Examination (EDE)
  • The Food Craving Inventory (FCI)
  • National Cancer Institute (NCI) ASA24
Other: Measurement of Functional gastric volume
The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.
Other: Measurement of gastric pouch and GJ size
Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Behavior Assessment scores will be compared between both groups
Time Frame: Greater than 2 years post RYGB
Eating behaviors will be determined by performing the Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), and the National Cancer Institute (NCI) ASA24.
Greater than 2 years post RYGB

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional gastric volume will be measured
Time Frame: Greater than 2 years post RYGB
The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.
Greater than 2 years post RYGB
Gastric pouch size and GJ diameter will be measured
Time Frame: Greater than 2 years post RYGB
Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
Greater than 2 years post RYGB

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Shelby Sullivan, MD, Washington University School of Medicine

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

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

October 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201409107

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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