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

September 12, 2016 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • right-handed
  • morbidly obese patients
  • scheduled for bariatric surgery

Exclusion Criteria:

  • Diabetes mellitus
  • cardiovascular disease
  • neurologic or psychiatric disorder

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Single intragastric instillation of 300ml tap water via nasogastric tube
Dietary supplement: Tap water
300ml tap water via nasogastric tube
Active Comparator: GLUCOSE
Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube
Dietary supplement: Glucose
300ml tap water with 75g glucose via nasogastric tube
Active Comparator: FRUCTOSE
Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube
Dietary supplement: Fructose
300ml tap water with 25g fructose via nasogastric tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow
Time Frame: changes from baseline to one hour after treatment
changes from baseline to one hour after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in plasma glucose
Time Frame: Changes from baseline to one hour after treatment
Changes from baseline to one hour after treatment
Changes in plasma insulin
Time Frame: Changes from baseline to one hour after treatment
Changes from baseline to one hour after treatment
Changes in Plasma GLP-1
Time Frame: Changes from baseline to one hour after treatment
Changes from baseline to one hour after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Chair: Christoph Beglinger, Prof, University of Basel

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

April 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • fMRI BARI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Exploratory Behavior

Clinical Trials on Tap water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe