Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160379
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne

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

Condition or disease Intervention/treatment
Obesity Other: standard test meal

Layout table for study information
Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Dynamic Effect of Gastrointestinal Hormones on Cerebral Mechanisms Involved in Brain Perception of Food Pictures After Bariatric Surgery
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160379


Locations
Layout table for location information
Switzerland
CHUV-clinical research center
Lausanne, VD, Switzerland, CH-1001
Sponsors and Collaborators
University of Lausanne
Investigators
Layout table for investigator information
Principal Investigator: Luc Tappy, MD University of Lausanne
Layout table for additonal information
Responsible Party: Luc Tappy, MD, Professor of Physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT02160379    
Other Study ID Numbers: 219/09
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Keywords provided by Luc Tappy, MD, University of Lausanne:
roux-en-Y-gastric bypass
brain responses to food
gastrointestinal hormones
bile acids