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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes Mellitus, Overweight

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients with glycemic unbalance despite anti-diabetic treatments and 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day). | Drug: Liraglutide<br>* 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.<br>* Other names: Novonordisk (Puteaux, France);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liking and wanting for protein, lipid and glucid foods |  | 3 months | 
| Change in sensory specific satiety for protein, lipid and glucid foods |  | 3 months | 
| Change in gustative detection thresholds for sweet, bitter and salty tastes |  | 3 months | 
| Change in appetite, desire to eat, pleasure in eating |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass composition (Dual Energy XRay Absorptiometry) |  | 3 months | 
| Change in plasma ghrelin, leptin, and HbA1c levels |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liraglutide, GLP-1 analogue, Food preference, Gustative perception, Liking, wanting, T2DM, body mass composition, leptin, ghrelin