Healthy Human Male SubjectsPhase 4NCT01695109
The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers
A Phase 4 study testing Liraglutide in people with Healthy Human Male Subjects, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1) mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be associated with changes in food choices, as suggested by animal studies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Male Subjects
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2010to Mar 2012
- Phase
- Phase 4
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy volunteers
- Age 20-40
- Non-smokers
- Normal body weight (body mass index 19 -25 kg/m2)
- Right handed
- Signed informed consent
- Willingness and ability to comply with the protocol
Who cannot join
- Any history of or current drug abuse including alcohol consumption on a regular basis or binge drinking
- Any history of or current psychiatric disease, including any eating disorder, as assessed by structured interview
- Any history of dieting
- Any condition interfering with fMRI measurements such as ferromagnetic implants or claustrophobia
- Any evidence of relevant renal, liver, thyroid, cardiovascular, or respiratory illness at screening examination
- Any acute illness necessitating medical treatment during the last 3 weeks before study entry, any permanent intake of medication
Show all 9Show fewer
- Any study participation in the last 3 months
- HIV, hepatitis B or C positive
- Any disease considered relevant for proper performance of the study or risks to the participant, at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Endocrinology and Metabolism, Medical University of Vienna
Vienna, 1090
About this study
Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1) mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be associated with changes in food choices, as suggested by animal studies. It has been shown that functional magnetic resonance imaging (fMRI) of the brain is a valuable tool in obesity research and can be used to study the response of several brain regions to the visual presentation of preferred in comparison to non preferred food items and to non food items The aim of this study is to search for possible effects of liraglutide in comparison to placebo on 1. food choices and 2. changes in brain function as evidenced by fMRI in healthy volunteers.
Findings of this study will help not only to get deeper insight into the mechanism of the anorexic effect of GLP-1 mimetics, but also into the regulation of food choices per se. In the future, it is planned to extend the results of this study in normal weight volunteers to obese diabetic subjects.
Read the detailed description
Design: The study is designed as a double blind, placebo controlled, randomized crossover intervention study with two arms (liraglutide first followed by placebo vs. placebo first followed by liraglutide) in 16 healthy male volunteers. fMRI results and food intake are compared between groups baseline vs. end of treatment period and placebo vs. liraglutide.
Intervention: A standard dose of 0.6 mg Liraglutide (oder placebo) will be used, and will be applied subcutaneously each morning for three subsequent days by the study personnel. Study sessions will be performed on the fourth day after placebo/liraglutide interventions.
Study sessions: On study days participants arrive at the trial centre at 8.00 am after a 12h fast. Participants are instructed to eat a light dinner around 8.00 pm the previous day and to spend around 8h resting during the night before the study days. Upon arrival, blood pressure and heart rate is measured and an iv line is started, from which a blood sample is taken from the antecubital vein for blood glucose, insulin and plasma hormone concentrations determination. The occurrence of nausea, vomiting, dizziness or any other adverse events (AE's) is reviewed together with the subject.
Instructions for the fMRI examination are reviewed together with the subject. The subject is advised to leave all ferromagnetic items behind, and baseline hunger/satiety visual analogue scales (VAS) are recorded. Then, the fMRI session with the food items paradigm (together with repeated recordings of hunger/satiety VAS) takes place. Afterwards, another blood sample and hunger/satiety VAS is taken and the subject is allowed to eat ad libitum from a buffet breakfast. Food intake is recorded in detail, including meal choices and calorie intake. After a final hunger/satiety VAS recording and another blood sample subjects are dismissed from the trial centre.
Outcome variables: Main outcome variables are fMRI activity in the brain during the high calorie/low calorie food items paradigm and food intake at the buffet liraglutide vs. placebo at the end of treatment. Secondary outcome parameters are hunger/satiety VAS ratings, total and active plasma ghrelin, peptide YY (PYY), glucose and insulin concentrations.
- Conditions
- Healthy Human Male Subjects
- Being tested
- Liraglutide, Placebo
- Keywords
- GLP1, obesity, fMRI, ghrelin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
sc injections of 0.6 mg Liraglutide daily for three continuous days.
PlaceboDrug
Also called Isotonic saline
0.9% NaCl, 0.2 ml
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Liraglutide | Active comparator | Not described Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake at an ad libitum buffet
Food intake at the ad libitum buffet under liraglutide vs. placebo will be measured in details: total amount of calories, and where these calories derive from
Measured: day 4
fMRI activity in the brain
fMRI activity in the brain during the high calorie/low calorie food items paradigm
Measured: day 4
Secondary outcomes (2)
Changes in hunger and satiety scores on the visual analogue scales (VAS) over time as compared to baseline (measured in mm) during the study session
Hunger-VAS forms include the question: How hungry do you feel? Subjects are required to mark their feeling of hunger in a scale of 0 to 100 mm.
Satiety-VAS forms include the question: How satt do you feel? Subjects are required to mark their feeling of satiety in a scale of 0 to 100 mm.
Measured: timepoints -10, 90, 130 minutes
Changes in Ghrelin, PYY, glucose and insulin concentrations during the study session
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C for the later measurement of insulin, ghrelin and PYY. All assays will be performed using commercial assay kits at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
Measured: timepoints -10, 90, 130 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Human Male SubjectsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anton Luger, Medical University of Vienna
- Investigators
- Anton Luger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695109
- Sponsor's protocol ID
- 702/2008
- Status last verified
- Sep 2012
- First submitted
- 19 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01695109
- Acronym / sponsor ID
- 702/2008
- Conditions
- Healthy Human Male Subjects
- Keywords
- GLP1, obesity, fMRI, ghrelin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Sep 2012 (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.
Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1) mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be associated with changes in food choices, as suggested by animal studies. It has been shown that functional magnetic resonance imaging (fMRI) of the brain is a valuable tool in obesity research and can be used to study the response of several brain regions to the visual presentation of preferred in comparison to non preferred food items and to non food items The aim of this study is to search for possible effects of liraglutide in comparison to placebo on 1. food choices and 2. changes in brain function as evidenced by fMRI in healthy volunteers.
Findings of this study will help not only to get deeper insight into the mechanism of the anorexic effect of GLP-1 mimetics, but also into the regulation of food choices per se. In the future, it is planned to extend the results of this study in normal weight volunteers to obese diabetic subjects.
Detailed description
Design: The study is designed as a double blind, placebo controlled, randomized crossover intervention study with two arms (liraglutide first followed by placebo vs. placebo first followed by liraglutide) in 16 healthy male volunteers. fMRI results and food intake are compared between groups baseline vs. end of treatment period and placebo vs. liraglutide.
Intervention: A standard dose of 0.6 mg Liraglutide (oder placebo) will be used, and will be applied subcutaneously each morning for three subsequent days by the study personnel. Study sessions will be performed on the fourth day after placebo/liraglutide interventions.
Study sessions: On study days participants arrive at the trial centre at 8.00 am after a 12h fast. Participants are instructed to eat a light dinner around 8.00 pm the previous day and to spend around 8h resting during the night before the study days. Upon arrival, blood pressure and heart rate is measured and an iv line is started, from which a blood sample is taken from the antecubital vein for blood glucose, insulin and plasma hormone concentrations determination. The occurrence of nausea, vomiting, dizziness or any other adverse events (AE's) is reviewed together with the subject.
Instructions for the fMRI examination are reviewed together with the subject. The subject is advised to leave all ferromagnetic items behind, and baseline hunger/satiety visual analogue scales (VAS) are recorded. Then, the fMRI session with the food items paradigm (together with repeated recordings of hunger/satiety VAS) takes place. Afterwards, another blood sample and hunger/satiety VAS is taken and the subject is allowed to eat ad libitum from a buffet breakfast. Food intake is recorded in detail, including meal choices and calorie intake. After a final hunger/satiety VAS recording and another blood sample subjects are dismissed from the trial centre.
Outcome variables: Main outcome variables are fMRI activity in the brain during the high calorie/low calorie food items paradigm and food intake at the buffet liraglutide vs. placebo at the end of treatment. Secondary outcome parameters are hunger/satiety VAS ratings, total and active plasma ghrelin, peptide YY (PYY), glucose and insulin concentrations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Liraglutide | Active comparator | Drug: Liraglutide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male healthy volunteers
- Age 20-40
- Non-smokers
- Normal body weight (body mass index 19 -25 kg/m2)
- Right handed
Key exclusion criteria (9 listed)
- Any history of or current drug abuse including alcohol consumption on a regular basis or binge drinking
- Any history of or current psychiatric disease, including any eating disorder, as assessed by structured interview
- Any history of dieting
- Any condition interfering with fMRI measurements such as ferromagnetic implants or claustrophobia
- Any evidence of relevant renal, liver, thyroid, cardiovascular, or respiratory illness at screening examination
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 |
|---|---|---|
| LiraglutideAlso: Victozasc injections of 0.6 mg Liraglutide daily for three continuous days. | Drug | Liraglutide |
| PlaceboAlso: Isotonic saline0.9% NaCl, 0.2 ml | Drug | Placebo |
Primary outcome
Food intake at an ad libitum buffet
Time frame: day 4
Food intake at the ad libitum buffet under liraglutide vs. placebo will be measured in details: total amount of calories, and where these calories derive from
fMRI activity in the brain
Time frame: day 4
fMRI activity in the brain during the high calorie/low calorie food items paradigm
2 secondary outcomes
Changes in hunger and satiety scores on the visual analogue scales (VAS) over time as compared to baseline (measured in mm) during the study session
Time frame: timepoints -10, 90, 130 minutes
Changes in Ghrelin, PYY, glucose and insulin concentrations during the study session
Time frame: timepoints -10, 90, 130 minutes
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 27 Sep 2012.
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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.
Anton Luger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Healthy Human Male Subjects, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 9 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 27 Sep 2012. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Food intake at an ad libitum buffet (time frame: day 4). The study lists 2 primary outcomes in all. 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 27 Sep 2012.