Exploratory BehaviorNCT02902224
Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery
A study testing Tap water, Glucose and Fructose in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Exploratory Behavior
- What is being tested?
- Tap water, Glucose and Fructose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- right-handed
- morbidly obese patients
- scheduled for bariatric surgery
Who cannot join
- Diabetes mellitus
- cardiovascular disease
- neurologic or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Exploratory Behavior
- Being tested
- Tap water, Glucose, Fructose
- Medical subject headings
- Exploratory Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tap waterDietary supplement
300ml tap water via nasogastric tube
GlucoseDietary supplement
300ml tap water with 75g glucose via nasogastric tube
FructoseDietary supplement
300ml tap water with 25g fructose via nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Single intragastric instillation of 300ml tap water via nasogastric tube Receives: Dietary Supplement: Tap water |
| GLUCOSE | Active comparator | Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube Receives: Dietary Supplement: Glucose |
| FRUCTOSE | Active comparator | Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube Receives: Dietary Supplement: Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow
Measured: changes from baseline to one hour after treatment
Secondary outcomes (3)
Changes in plasma glucose
Measured: Changes from baseline to one hour after treatment
Changes in plasma insulin
Measured: Changes from baseline to one hour after treatment
Changes in Plasma GLP-1
Measured: Changes from baseline to one hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploratory BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, Prof, Study chair, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902224
- Sponsor's protocol ID
- fMRI BARI
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02902224
- Acronym / sponsor ID
- fMRI BARI
- Conditions
- Exploratory Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Dietary Supplement: Tap waterSingle intragastric instillation of 300ml tap water via nasogastric tube |
| GLUCOSE | Active comparator | Dietary Supplement: GlucoseSingle intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube |
| FRUCTOSE | Active comparator | Dietary Supplement: FructoseSingle intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- right-handed
- morbidly obese patients
- scheduled for bariatric surgery
Key exclusion criteria (3 listed)
- Diabetes mellitus
- cardiovascular disease
- neurologic or psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tap water300ml tap water via nasogastric tube | Dietary supplement | PLACEBO |
| Glucose300ml tap water with 75g glucose via nasogastric tube | Dietary supplement | GLUCOSE |
| Fructose300ml tap water with 25g fructose via nasogastric tube | Dietary supplement | FRUCTOSE |
Primary outcome
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
3 secondary outcomes
Changes in plasma glucose
Time frame: Changes from baseline to one hour after treatment
Changes in plasma insulin
Time frame: Changes from baseline to one hour after treatment
Changes in Plasma GLP-1
Time frame: Changes from baseline to one hour after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, Prof study chair
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tap water, Glucose and Fructose in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.