ObesityNCT02160379
Effects of Roux-en-Y Gastric Bypass on Gastro-intestinal Hormone Secretion and Brain Responses Food Pictures
An observational study of Obesity, run by University of Lausanne at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- standard test meal
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Formerly obese patients attending the obesity clinics of Lausanne University Hospital and healthy subjects resident in the Lausanne area
Who may be able to join
- good apparent health
- gender: female
- age 18-50
- non-smoker
Who cannot join
- diabetes or antidiabetic medication
- consumption of more than 50g alcohol per week
- vegetarian or any special diet
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV-clinical research center
Lausanne, Canton of Vaud, CH-1001
About this study
Official title: 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
- Conditions
- Obesity
- Being tested
- standard test meal
- Keywords
- roux-en-Y-gastric bypass, brain responses to food, gastrointestinal hormones, bile acids
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard test mealOther
| Study group | Role | What they receive |
|---|---|---|
| post Roux-en-Y-gastric bypass | Formerly obese females 1-5 years after gastric bypass Receives: Other: standard test meal | |
| matched controls | non-operated females age-and weight-matched to post Roux-en-Y-gastric bypass subjects Receives: Other: standard test meal | |
| healthy young controls | non overweight (BMI between 19 and 25 kg/m2) healthy females Receives: Other: standard test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: basal, 120 min postprandial and 240 postprandial
Secondary outcomes (5)
changes in plasma triglyceride concentration after ingestion of a meal
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)
Measured: basal, 90 min postprandial and 180 postprandial
Changes in plasma glucoincretins (GLP1 and GIP) concentrations after ingestion of a meal
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)
Measured: basal, 90 min postprandial and 180 postprandial
Changes in plasma cholecystokinin concentrations after ingestion of a meal
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)
Measured: basal, 90 min postprandial and 180 postprandial
Changes in plasma bile acids concentrations after ingestion of a meal
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)
Measured: basal, 90 min postprandial and 180 postprandial
changes in plasma glucoregulatory status after ingestion of a meal
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)
Measured: basal, 90 min postprandial and 180 postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160379
- Sponsor's protocol ID
- 219/09
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Effect of Gastrointestinal Hormones on Cerebral Mechanisms Involved in Brain Perception of Food Pictures After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02160379
- Acronym / sponsor ID
- 219/09
- Conditions
- Obesity
- Keywords
- roux-en-Y-gastric bypass, brain responses to food, gastrointestinal hormones, bile acids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| post Roux-en-Y-gastric bypass | – | Other: standard test mealFormerly obese females 1-5 years after gastric bypass |
| matched controls | – | Other: standard test mealnon-operated females age-and weight-matched to post Roux-en-Y-gastric bypass subjects |
| healthy young controls | – | Other: standard test mealnon overweight (BMI between 19 and 25 kg/m2) healthy females |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Formerly obese patients attending the obesity clinics of Lausanne University Hospital and healthy subjects resident in the Lausanne area
Key inclusion criteria (4 listed)
- good apparent health
- gender: female
- age 18-50
- non-smoker
Key exclusion criteria (3 listed)
- diabetes or antidiabetic medication
- consumption of more than 50g alcohol per week
- vegetarian or any special diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard test meal | Other | healthy young controls, matched controls, post Roux-en-Y-gastric bypass |
Primary outcome
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
5 secondary outcomes
changes in plasma triglyceride concentration after ingestion of a meal
Time frame: 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
Changes in plasma cholecystokinin concentrations after ingestion of a meal
Time frame: 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
changes in plasma glucoregulatory status after ingestion of a meal
Time frame: basal, 90 min postprandial and 180 postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Tappy, MD principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of visually-evoked EEG potentials after ingestion of a meal (time frame: basal, 120 min postprandial and 240 postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.