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Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients

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: NCT01599338
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : June 1, 2012
Information provided by (Responsible Party):
Marie Claude Brindisi, Centre Hospitalier Universitaire Dijon

Brief Summary:

Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1 analogues decrease satiety and food intake leading to a significant weight loss in patients. However, little is known about their effects on food hedonic sensations and taste perception.

The aim of this study is to investigate the impact of Liraglutide on the liking and wanting components of the food reward system, taste sensitivity and sensory specific satiety in type 2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models, it is expected that Liraglutide will modify food preference and gustative perception in humans.

Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the treatment administration. Olfactory liking, recalled liking and wanting for several food items will be assessed. Sensory specific satiety will be measured as well as detection thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on hunger, pleasure in eating, and food intake.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Overweight Drug: Liraglutide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Influence du Victoza (Liraglutide,Analogue GLP-1) Sur Les Performances Gustatives, le Rassasiement Sensoriel spécifique, le Liking et le Wanting Chez Les Patients diabétiques de Type 2.
Study Start Date : January 2011
Actual Primary Completion Date : January 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).
Drug: Liraglutide
3 months of treatment by Liraglutide (self-administration). The initial dose was 0.6 mg/day subcutaneously during five days, then uptitrated to a daily dose of 1.2 mg during three months.
Other Name: Novonordisk (Puteaux, France)

Primary Outcome Measures :
  1. Change in liking and wanting for protein, lipid and glucid foods [ Time Frame: 3 months ]
  2. Change in sensory specific satiety for protein, lipid and glucid foods [ Time Frame: 3 months ]
  3. Change in gustative detection thresholds for sweet, bitter and salty tastes [ Time Frame: 3 months ]
  4. Change in appetite, desire to eat, pleasure in eating [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in body mass composition (Dual Energy XRay Absorptiometry) [ Time Frame: 3 months ]
  2. Change in plasma ghrelin, leptin, and HbA1c levels [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Type 2 diabetic patients

  1. with glycemic unbalance despite anti-diabetic treatments and
  2. overweight (BMI > 25 kg/m²)

Exclusion Criteria:

  • Impaired renal function (creatinine clearance < 50 ml/min),
  • Pregnancy,
  • Congestive heart failure,
  • Acute and chronic infection,
  • Evolutive cancer,
  • Cirrhosis,
  • Ongoing antibiotic treatment,
  • Smoking (more than 5 cig/day),
  • Alcohol consumption (more than 20 g/day),
  • Aversion for the foods eaten or smelt during the study,
  • Impaired comprehension for cognitive tasks,
  • Treatments known to interfere with olfactory and gustative performances

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): NCT01599338

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CHU Dijon
Dijon, Bourgogne, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Principal Investigator: Marie-Claude Brindisi, MD CHU Dijon
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Responsible Party: Marie Claude Brindisi, MD, Centre Hospitalier Universitaire Dijon Identifier: NCT01599338    
Other Study ID Numbers: A100991-10
2010-022618-19 ( EudraCT Number )
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Marie Claude Brindisi, Centre Hospitalier Universitaire Dijon:
GLP-1 analogue
Food preference
Gustative perception
body mass composition
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists