Clinical trial NCT01599338: Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Overweight
Keywords: Liraglutide
GLP-1 analogue
Food preference
Gustative perception
Liking
wanting
T2DM
body mass composition
leptin
ghrelin
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in liking and wanting for protein, lipid and glucid foods
timeFrame: 3 months
measure: Change in sensory specific satiety for protein, lipid and glucid foods
timeFrame: 3 months
measure: Change in gustative detection thresholds for sweet, bitter and salty tastes
timeFrame: 3 months
measure: Change in appetite, desire to eat, pleasure in eating
timeFrame: 3 months
Secondary outcomes:
measure: Change in body mass composition (Dual Energy XRay Absorptiometry)
timeFrame: 3 months
measure: Change in plasma ghrelin, leptin, and HbA1c levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
state: Bourgogne
Study officials:
affiliation: CHU Dijon
name: Marie-Claude Brindisi, MD
role: PRINCIPAL_INVESTIGATOR
References: