The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity

August 5, 2013 updated by: University Hospital, Basel, Switzerland

The Role of Endogenous GLP-1 in Regulating Glucose Stimulated Brain Activity

Our objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose with and without lactisole and exendin as well as fructose is followed by functional brain MRI, and findings are correlated with serum GLP-1 levels as an endogenous satiety signal in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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, CH-4031
        • University Hospital

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

  • drug abuse, smoker, left-handed, claustrophobia

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 300ml tap water
Single intragastric instillation of 300ml tap water via nasogastric tube
Dietary supplement: tap water
Active Comparator: Glucose
Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube
Dietary supplement: Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube
Active Comparator: Glucose plus Lactisole
Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole
Dietary supplement: Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole
Active Comparator: Fructose
Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube
Dietary supplement: 25g Fructose in 300ml tap water
Active Comparator: Glucose and Exendin
Single intragastric instillation of 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39
Dietary supplement: 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39
Sham Comparator: tap water, lactisole
Single intragastric instillation of 300ml tap water with 450ppm lactisole
Dietary supplement: 300ml tap water with 450ppm lactisole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task: changes in cerebral blood flow and blood hormones from baseline to treatment
Time Frame: changes from baseline to one hour after treatment
Whole brain analysis with a cluster-level threshold was followed by an a priori defined region of interest analysis of the dorsolateral prefrontal cortex including a cluster-level threshold and family-wise error adjustment for multiple comparisons.
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

  • Principal Investigator: Christoph Beglinger, MD, University Hospital, Basel, Switzerland

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

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • EKBB 298/12

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.

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