- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02589613
Glucose and Fructose Stimulated Brain Activity in Obese Subjects
October 26, 2015 updated by: University Hospital, Basel, Switzerland
Effects of Acute Glucose and Fructose Ingestion on Brain Activity in Obese Volunteers
The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI.
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)
12
Phase
- Not Applicable
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 45 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: PLACEBO
Single intragastric instillation of 300ml tap water via nasogastric tube
|
300ml tap water via nasogastric tube
|
|
Active Comparator: GLUCOSE
Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube
|
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
|
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 insulin
Time Frame: changes from baseline to one hour after treatment
|
changes from baseline to one hour after treatment
|
|
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 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.
Investigators
- Study Chair: Christoph Beglinger, MD, 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
October 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
October 20, 2015
First Submitted That Met QC Criteria
October 26, 2015
First Posted (Estimate)
October 28, 2015
Study Record Updates
Last Update Posted (Estimate)
October 28, 2015
Last Update Submitted That Met QC Criteria
October 26, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- fMRI Obese
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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