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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022618-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Type 2 diabetic patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Claude Brindisi, MD | CHU Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon | Dijon | Bourgogne-Franche-Comté | 21000 | France |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |