Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery

Exploratory Behavior Clinical Trial

Official title:

Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902224
• Other study ID #: fMRI BARI
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: September 12, 2016
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI before and after bariatric surgery. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• right-handed

• morbidly obese patients

• scheduled for bariatric surgery

Exclusion Criteria:

• Diabetes mellitus

• cardiovascular disease

• neurologic or psychiatric disorder

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exploratory Behavior

Intervention

Dietary Supplement:
• Tap water
300ml tap water via nasogastric tube
• Glucose
300ml tap water with 75g glucose via nasogastric tube
• Fructose
300ml tap water with 25g fructose via nasogastric tube

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow		changes from baseline to one hour after treatment	No
Secondary	Changes in plasma glucose		Changes from baseline to one hour after treatment	No
Secondary	Changes in plasma insulin		Changes from baseline to one hour after treatment	No
Secondary	Changes in Plasma GLP-1		Changes from baseline to one hour after treatment	No