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

NCT01695109 | Completed Phase 4

• 1 other identifier: 702/2008
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Human Male Subjects

Keywords

GLP1; obesity; fMRI; ghrelin

Outcome Measures

Primary Outcomes (2)

• 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

  day 4

• fMRI activity in the brain

  fMRI activity in the brain during the high calorie/low calorie food items paradigm

  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

  timepoints -10, 90, 130 minutes

• Changes in Ghrelin, PYY, glucose and insulin concentrations during the study session

  timepoints -10, 90, 130 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Liraglutide

ACTIVE COMPARATOR

Drug: Liraglutide

Interventions

Liraglutide DRUG

sc injections of 0.6 mg Liraglutide daily for three continuous days.

Also known as: Victoza

Liraglutide

Placebo DRUG

0.9% NaCl, 0.2 ml

Also known as: Isotonic saline

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Division of Endocrinology and Metabolism, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anton Luger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Endocrinology & Metabolism

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 27, 2012
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

AU (1)