Effects of Roux-en-Y Gastric Bypass on Gastro-intestinal Hormone Secretion and Brain Responses Food Pictures

June 6, 2014 updated by: Luc Tappy, MD, University of Lausanne

Dynamic Effect of Gastrointestinal Hormones on Cerebral Mechanisms Involved in Brain Perception of Food Pictures After Bariatric Surgery

This is a cross-sectional study enrolling

  • 11 weight-stable, formerly obese female patients 1-5 years after Roux-en-Y gastric Bypass (RYGB)
  • 11 age- and weight-matched female subjects
  • 10 normal weight (Body Mass Index 19-25 kg/m2) subjects The following measurements will be performed in each participants in basal conditions (after an overnight fast) and after ingestion of a standard meal
  • electroencephalographic recordings of visually evoked potential after presentation of food- or non-food pictures
  • plasma concentration of metabolites (glucose, fatty acids), glucoregulatory hormones (insulin, glucagon), gastro-intestinal hormones (Gastric Inhibitory Polypeptide (GIP), Glucagon-like Peptide-1 (GLP1), ghrelin,Cholecystokinin (CCK), and bile acids Aims of this observational study are
  • to evaluate the effects of RYGB on brain perception of food related visual stimulation
  • to search for relationships between RYGB effects on brain responses and gastro-intestinal hormone secretion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

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

    • VD
      • Lausanne, VD, Switzerland, CH-1001
        • CHUV-clinical research 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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Formerly obese patients attending the obesity clinics of Lausanne University Hospital and healthy subjects resident in the Lausanne area

Description

Inclusion Criteria:

  • good apparent health
  • gender: female
  • age 18-50
  • non-smoker

Exclusion Criteria:

  • diabetes or antidiabetic medication
  • consumption of more than 50g alcohol per week
  • vegetarian or any special diet

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
post Roux-en-Y-gastric bypass
Formerly obese females 1-5 years after gastric bypass
matched controls
non-operated females age-and weight-matched to post Roux-en-Y-gastric bypass subjects
healthy young controls
non overweight (BMI between 19 and 25 kg/m2) healthy females

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of visually-evoked EEG potentials after ingestion of a meal
Time Frame: basal, 120 min postprandial and 240 postprandial
Recording and analysis of visual evoked potentials (VEPs) while patients categorize photographs of foods and non-food kitchen utensils
basal, 120 min postprandial and 240 postprandial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in plasma triglyceride concentration after ingestion of a meal
Time Frame: basal, 90 min postprandial and 180 postprandial
Measurement of triglyceride concentrations at 30-60 min intervals in basal conditions (after an overnight fast) and over 6 hours after ingestion of a standard meal)
basal, 90 min postprandial and 180 postprandial
Changes in plasma glucoincretins (GLP1 and GIP) concentrations after ingestion of a meal
Time Frame: basal, 90 min postprandial and 180 postprandial
Measurement of GLP1 and GIP concentrations at 30-60 min intervals in basal conditions (after an overnight fast) and over 6 hours after ingestion of a standard meal)
basal, 90 min postprandial and 180 postprandial
Changes in plasma cholecystokinin concentrations after ingestion of a meal
Time Frame: basal, 90 min postprandial and 180 postprandial
Measurement of cholecystokinin concentrations at 30-60 min intervals in basal conditions (after an overnight fast) and over 6 hours after ingestion of a standard meal)
basal, 90 min postprandial and 180 postprandial
Changes in plasma bile acids concentrations after ingestion of a meal
Time Frame: basal, 90 min postprandial and 180 postprandial
Measurement of bile acids concentrations at 30-60 min intervals in basal conditions (after an overnight fast) and over 6 hours after ingestion of a standard meal)
basal, 90 min postprandial and 180 postprandial
changes in plasma glucoregulatory status after ingestion of a meal
Time Frame: basal, 90 min postprandial and 180 postprandial
Measurement of glucose, insulin, glucagon and non-esterified fatty acid concentrations at 30-60 min intervals in basal conditions (after an overnight fast) and over 6 hours after ingestion of a standard meal)
basal, 90 min postprandial and 180 postprandial

Collaborators and Investigators

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

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

January 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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