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The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695109
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : September 27, 2012
Information provided by (Responsible Party):
Anton Luger, Medical University of Vienna

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Human Male Subjects Drug: Liraglutide Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers
Study Start Date : November 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
0.9% NaCl, 0.2 ml
Other Name: Isotonic saline

Active Comparator: Liraglutide Drug: Liraglutide
sc injections of 0.6 mg Liraglutide daily for three continuous days.
Other Name: Victoza

Primary Outcome Measures :
  1. 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

  2. fMRI activity in the brain [ Time Frame: day 4 ]
    fMRI activity in the brain during the high calorie/low calorie food items paradigm

Secondary Outcome Measures :
  1. 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 ]

    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.

  2. Changes in Ghrelin, PYY, glucose and insulin concentrations during the study session [ Time Frame: timepoints -10, 90, 130 minutes ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695109

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Division of Endocrinology and Metabolism, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Anton Luger, MD Medical University of Vienna

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Responsible Party: Anton Luger, Head of the Department of Endocrinology & Metabolism, Medical University of Vienna Identifier: NCT01695109     History of Changes
Other Study ID Numbers: 702/2008
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Anton Luger, Medical University of Vienna:

Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists