Microstructural Analysis of Ingestive Behavior After Roux-en-Y Gastric Bypass - Pilot

NCT03747445 | Completed

• 1 other identifier: 2017-00756-2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The ability to assess ingestion in fine detail over the time course of a liquid meal allows for comparison of early and late meal features of drinking and may help dissociate manipulations (surgical, neural, pharmacological, etc.) that affect orosensory properties from those that are modulating postoral processes in the control of intake. The aim of the study is to asses microstructural changes in liquid meal intake over 1-year in severely obese patients after Roux-en-Y gastric bypass (RYGB).

Conditions

Meal; Obesity, Morbid; Food Deprivation; Bariatric Surgery; Roux-en-y Gastric Bypass; Ingestive Microstructure; Drinking Behavior; Drinkometer

Outcome Measures

Primary Outcomes (1)

• change in microstructure of ingestive behavior of 1 liquid meal

  recording of meal intake by the drinkometer

  baseline, 1 week, 1-3-6-12 months

Secondary Outcomes (2)

• change in self-reported hunger, thirst, fullness, taste preference, estimated consumption

  baseline, 1 week, 1-3-6-12 months

• body mass index

  baseline, 1 week, 1-3-6-12 months

Study Arms (3)

Roux-en-Y gastric bypass patients

severely obese non-diabetic adult female patients scheduled for RYGB

Procedure: Roux-en-Y gastric bypass

Normal weight controls

normal weight healthy non-diabetic adult females

Obese controls

Severely obese non-diabetic adult female patients not scheduled for RYGB

Interventions

Roux-en-Y gastric bypass PROCEDURE

laparoscopic surgical procedure

Roux-en-Y gastric bypass patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females with severe obesity and scheduled to undergo RYGB

You may qualify if:

• ability to provide inform consent
• treatment group: scheduled for RYGB for severe obesity
• control group: normal weight, healthy general condition

You may not qualify if:

• lactose intolerance
• diabetes
• immunosuppression
• pregnancy / lactation
• use of weight-loss medication

Sponsors & Collaborators

• Marco Bueter: lead
• Department of Psychology and Program in Neuroscience, Florida State University, Tallahassee, FL, USA: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (6)

• Gero D, File B, Justiz J, Steinert RE, Frick L, Spector AC, Bueter M. Drinking microstructure in humans: A proof of concept study of a novel drinkometer in healthy adults. Appetite. 2019 Feb 1;133:47-60. doi: 10.1016/j.appet.2018.08.012. Epub 2018 Sep 1.

  PMID: 30179650 BACKGROUND

• Gero D, Steinert RE, le Roux CW, Bueter M. Do Food Preferences Change After Bariatric Surgery? Curr Atheroscler Rep. 2017 Sep;19(9):38. doi: 10.1007/s11883-017-0674-x.

  PMID: 28779431 BACKGROUND

• Mathes CM, Bohnenkamp RA, Blonde GD, Letourneau C, Corteville C, Bueter M, Lutz TA, le Roux CW, Spector AC. Gastric bypass in rats does not decrease appetitive behavior towards sweet or fatty fluids despite blunting preferential intake of sugar and fat. Physiol Behav. 2015 Apr 1;142:179-88. doi: 10.1016/j.physbeh.2015.02.004. Epub 2015 Feb 3.

  PMID: 25660341 BACKGROUND

• Spector AC, Klumpp PA, Kaplan JM. Analytical issues in the evaluation of food deprivation and sucrose concentration effects on the microstructure of licking behavior in the rat. Behav Neurosci. 1998 Jun;112(3):678-94. doi: 10.1037//0735-7044.112.3.678.

  PMID: 9676983 BACKGROUND

• Johnson AW. Characterizing ingestive behavior through licking microstructure: Underlying neurobiology and its use in the study of obesity in animal models. Int J Dev Neurosci. 2018 Feb;64:38-47. doi: 10.1016/j.ijdevneu.2017.06.012. Epub 2017 Jul 3.

  PMID: 28684308 BACKGROUND

• Gero D, File B, Alceste D, Frick LD, Serra M, Ismaeil AE, Steinert RE, Spector AC, Bueter M. Microstructural changes in human ingestive behavior after Roux-en-Y gastric bypass during liquid meals. JCI Insight. 2021 Aug 9;6(15):e136842. doi: 10.1172/jci.insight.136842.

  PMID: 34369388 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Drinking Behavior

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Marco Bueter, MD, PhD

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, PhD, Head of Bariatric Program

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: February 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)