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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Switzerland
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
post Roux-en-Y-gastric bypass
Formerly obese females 1-5 years after gastric bypass
Other: standard test meal
matched controls
non-operated females age-and weight-matched to post Roux-en-Y-gastric bypass subjects
Other: standard test meal
healthy young controls
non overweight (BMI between 19 and 25 kg/m2) healthy females
Other: standard test meal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lausanne

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 219/09

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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