## Protocol Section
### Identification Module
**NCT ID:** NCT02160379

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

**Official Title:** Dynamic Effect of Gastrointestinal Hormones on Cerebral Mechanisms Involved in Brain Perception of Food Pictures After Bariatric Surgery

#### Organization Study ID Info
**ID:** 219/09
#### Organization
**Class:** OTHER
**Full Name:** University of Lausanne
### Status Module
#### Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-06-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-06-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2014-06

#### Study First Post Date
**Date:** 2014-06-10
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-04
**Study First Submit QC Date:** 2014-06-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Lausanne

#### Responsible Party

**Investigator Affiliation:** University of Lausanne

**Investigator Full Name:** Luc Tappy, MD

**Investigator Title:** Professor of Physiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- roux-en-Y-gastric bypass

- brain responses to food

- gastrointestinal hormones

- bile acids

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Formerly obese females 1-5 years after gastric bypass

**Intervention Names:**

- Other: standard test meal

**Label:** post Roux-en-Y-gastric bypass

#### Arm Group 2

**Description:** non-operated females age-and weight-matched to post Roux-en-Y-gastric bypass subjects

**Intervention Names:**

- Other: standard test meal

**Label:** matched controls

#### Arm Group 3

**Description:** non overweight (BMI between 19 and 25 kg/m2) healthy females

**Intervention Names:**

- Other: standard test meal

**Label:** healthy young controls

### Interventions

#### Intervention 1

**Arm Group Labels:**

- healthy young controls

- matched controls

- post Roux-en-Y-gastric bypass

**Name:** standard test meal

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Recording and analysis of visual evoked potentials (VEPs) while patients categorize photographs of foods and non-food kitchen utensils

**Measure:** Changes of visually-evoked EEG potentials after ingestion of a meal

**Time Frame:** basal, 120 min postprandial and 240 postprandial

#### Secondary Outcomes

**Description:** 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)

**Measure:** changes in plasma triglyceride concentration after ingestion of a meal

**Time Frame:** basal, 90 min postprandial and 180 postprandial

**Description:** 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)

**Measure:** Changes in plasma glucoincretins (GLP1 and GIP) concentrations after ingestion of a meal

**Time Frame:** basal, 90 min postprandial and 180 postprandial

**Description:** 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)

**Measure:** Changes in plasma cholecystokinin concentrations after ingestion of a meal

**Time Frame:** basal, 90 min postprandial and 180 postprandial

**Description:** 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)

**Measure:** Changes in plasma bile acids concentrations after ingestion of a meal

**Time Frame:** basal, 90 min postprandial and 180 postprandial

**Description:** 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)

**Measure:** changes in plasma glucoregulatory status after ingestion of a meal

**Time Frame:** basal, 90 min postprandial and 180 postprandial

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lausanne

**Country:** Switzerland

**Facility:** CHUV-clinical research center

**State:** VD

**Zip:** CH-1001

#### Overall Officials

**Official 1:**

**Affiliation:** University of Lausanne

**Name:** Luc Tappy, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M4933

- Name: Bile Acids and Salts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
