Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT01599338|
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : June 1, 2012
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).
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)
- Change in liking and wanting for protein, lipid and glucid foods [ Time Frame: 3 months ]
- Change in sensory specific satiety for protein, lipid and glucid foods [ Time Frame: 3 months ]
- Change in gustative detection thresholds for sweet, bitter and salty tastes [ Time Frame: 3 months ]
- Change in appetite, desire to eat, pleasure in eating [ Time Frame: 3 months ]
- Change in body mass composition (Dual Energy XRay Absorptiometry) [ Time Frame: 3 months ]
- Change in plasma ghrelin, leptin, and HbA1c levels [ Time Frame: 3 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01599338
|Dijon, Bourgogne, France, 21000|
|Principal Investigator:||Marie-Claude Brindisi, MD||CHU Dijon|