- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160379
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
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.
Sponsor
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
Other Study ID 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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