Exploratory BehaviorNCT01918566
The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity
A study testing tap water, Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube and Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exploratory Behavior
- What is being tested?
- tap water, Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube and Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Mar 2013
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed healthy males, no drugs, non-smoking
Who cannot join
- drug abuse, smoker, left-handed, claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Exploratory Behavior
- Being tested
- tap water, Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube, Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole, 25g Fructose in 300ml tap water, 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39
- 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
Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tubeDietary supplement
Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisoleDietary supplement
25g Fructose in 300ml tap waterDietary supplement
75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39Dietary supplement
300ml tap water with 450ppm lactisoleDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 300ml tap water | 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: Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube |
| Glucose plus Lactisole | Active comparator | Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole Receives: Dietary Supplement: Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole |
| Fructose | Active comparator | Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube Receives: Dietary Supplement: 25g Fructose in 300ml tap water |
| Glucose and Exendin | Active comparator | Single intragastric instillation of 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39 Receives: Dietary Supplement: 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39 |
| tap water, lactisole | Sham comparator | Single intragastric instillation of 300ml tap water with 450ppm lactisole Receives: Dietary Supplement: 300ml tap water with 450ppm lactisole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
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 posted7 Aug 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918566
- Sponsor's protocol ID
- EKBB 298/12
- Status last verified
- Aug 2013
- First submitted
- 8 May 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endogenous GLP-1 in Regulating Glucose Stimulated Brain Activity
- ClinicalTrials.gov ID
- NCT01918566
- Acronym / sponsor ID
- EKBB 298/12
- Conditions
- Exploratory Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Aug 2013 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 300ml tap water | Placebo comparator | Dietary Supplement: tap waterSingle intragastric instillation of 300ml tap water via nasogastric tube |
| Glucose | Active comparator | Dietary Supplement: Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tubeSingle intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube |
| Glucose plus Lactisole | Active comparator | Dietary Supplement: Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisoleSingle intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole |
| Fructose | Active comparator | Dietary Supplement: 25g Fructose in 300ml tap waterSingle intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube |
| Glucose and Exendin | Active comparator | Dietary Supplement: 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39Single intragastric instillation of 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39 |
| tap water, lactisole | Sham comparator | Dietary Supplement: 300ml tap water with 450ppm lactisoleSingle intragastric instillation of 300ml tap water with 450ppm lactisole |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- right-handed healthy males, no drugs, non-smoking
Key exclusion criteria (1 listed)
- drug abuse, smoker, left-handed, claustrophobia
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 water | Dietary supplement | 300ml tap water |
| Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube | Dietary supplement | Glucose |
| Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole | Dietary supplement | Glucose plus Lactisole |
| 25g Fructose in 300ml tap water | Dietary supplement | Fructose |
| 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39 | Dietary supplement | Glucose and Exendin |
| 300ml tap water with 450ppm lactisole | Dietary supplement | tap water, lactisole |
Primary outcome
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.
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 7 Aug 2013.
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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, MD principal investigator
University Hospital, Basel, Switzerland
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, Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube and Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole 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 1 inclusion and 1 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 7 Aug 2013. 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 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). 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 7 Aug 2013.