NCT02160379

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

June 4, 2014

Last Update Submit

June 6, 2014

Conditions

Obesity

Keywords

roux-en-Y-gastric bypassbrain responses to foodgastrointestinal hormonesbile acids

Outcome Measures

Primary Outcomes (1)

  • Changes of visually-evoked EEG potentials after ingestion of a meal

    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 Outcomes (5)

  • changes in plasma triglyceride concentration after ingestion of a meal

    basal, 90 min postprandial and 180 postprandial

  • Changes in plasma glucoincretins (GLP1 and GIP) concentrations after ingestion of a meal

    basal, 90 min postprandial and 180 postprandial

  • Changes in plasma cholecystokinin concentrations after ingestion of a meal

    basal, 90 min postprandial and 180 postprandial

  • Changes in plasma bile acids concentrations after ingestion of a meal

    basal, 90 min postprandial and 180 postprandial

  • changes in plasma glucoregulatory status after ingestion of a meal

    basal, 90 min postprandial and 180 postprandial

Study Arms (3)

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

Interventions

standard test mealOTHER
healthy young controlsmatched controlspost Roux-en-Y-gastric bypass

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV-clinical research center

Lausanne, Canton of Vaud, CH-1001, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luc Tappy, MD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physiology

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 10, 2014

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

CH(1)