Roux-en-Y Gastric Bypass and Weight Regain

NCT02302898 | Completed

• 1 other identifier: 201409107
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Roux-en-Y Gastric Bypass Surgery; Weight Regain

Outcome Measures

Primary Outcomes (1)

• Eating Behavior Assessment scores will be compared between both groups

  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 Outcomes (2)

• Functional gastric volume will be measured

  Greater than 2 years post RYGB

• Gastric pouch size and GJ diameter will be measured

  Greater than 2 years post RYGB

Study Arms (2)

Wt maintenance

Eating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes

Behavioral: Eating Behavior Evaluation; Other: Measurement of Functional gastric volume; Other: Measurement of gastric pouch and GJ size

Wt Regain

Eating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes

Behavioral: Eating Behavior Evaluation; Other: Measurement of Functional gastric volume; Other: Measurement of gastric pouch and GJ size

Interventions

Eating Behavior Evaluation BEHAVIORAL

Scores will be measured on binge eating behaviors and an increased craving for sweets.

Also known as: Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), National Cancer Institute (NCI) ASA24

Wt Regain; Wt maintenance

Measurement of Functional gastric volume OTHER

The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.

Wt Regain; Wt maintenance

Measurement of gastric pouch and GJ size OTHER

Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.

Wt Regain; Wt maintenance

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (42)

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MeSH Terms

Conditions

Obesity

Interventions

National Cancer Institute (U.S.)

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

National Institutes of Health (U.S.); Academies and Institutes; Organizations; Health Care Economics and Organizations; United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government

Study Officials

• Shelby Sullivan, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 27, 2014
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)