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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160379
• Other study ID #: 219/09
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: June 6, 2014
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2014
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: University of Lausanne
• Study type: Observational

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• standard test meal

Locations

Country	Name	City	State
Switzerland	CHUV-clinical research center	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	basal, 90 min postprandial and 180 postprandial	No
Secondary	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)	basal, 90 min postprandial and 180 postprandial	No
Secondary	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)	basal, 90 min postprandial and 180 postprandial	No
Secondary	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)	basal, 90 min postprandial and 180 postprandial	No
Secondary	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)	basal, 90 min postprandial and 180 postprandial	No