Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research. Distribution in groups 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1) 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2) 30 healthy subjects (non-diabetics) (group 3) This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).

Official Title
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Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Overweight

Intervention / Treatment
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* Drug: Liraglutide
* Other: Observation alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE persons who have provided written informed consent aged > 18 years type 2 diabetes with HbA1C > 7% overweight (BMI > 27) normal renal function (creatinine clearance > 50ml/min) patients to be treated with Liraglutide (patients with type 2 diabetes with HbA1C > 7.5% and overweight or obesity, whose current treatment is insufficient to control the diabetes). CONTROL DIABETIC PATIENTS persons who have provided written informed consent aged > 18 years type 2 diabetes with HbA1C > 7% overweight (BMI > 27) patients for whom treatment with Liraglutide is not indicated normal renal function (creatinine clearance > 50ml/min) HEALTHY SUBJECTS persons who have provided written informed consent aged > 18 years Exclusion Criteria: DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE type 1 diabetes decompensated congestive heart failure acute or chronic infection, progressive cancer, liver cirrhosis ongoing treatment with antibiotics smoking chronic alcohol abuse (>4 glasses a day) aversion to the products to be eaten or smelled poor understanding of the cognitive tasks requested treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs persons without national health insurance cover persons under guardianship hypersensitivity to Liraglutide pregnancy, breastfeeding history of acute or chronic pancreatitis calcitonin level at selection ≥ 50 ng/L liver disease, defined by a level of alanine aminotransferase (ALAT) ≥ 2.5 times the upper limit of normal (ULN) for reference values CONTROL DIABETIC PATIENTS type 1 diabetes, decompensated congestive heart failure, acute or chronic infection, progressive cancer, liver cirrhosis, ongoing treatment with antibiotics, smoking chronic alcohol abuse (> 4 glasses a day), aversion to the products to be eaten or smelled, poor understanding of the cognitive tasks requested, treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs. persons without national health insurance cover persons under guardianship HEALTHY SUBJECTS diabetes (type I and II) sensory disorders decompensated congestive heart failure, acute or chronic infection, progressive cancer, liver cirrhosis, ongoing treatment with antibiotics, smoking chronic alcohol abuse (> 4 glasses a day), aversion to the products to be eaten or smelled, poor understanding of the cognitive tasks requested, treatment interfering with olfactogustatory performance (psychotropic, anti-emetic, anti-ulcer drugs) persons without national health insurance cover persons under guardianship contra-indications to MRI, notably, but not limited to: pace maker, implantable cardiac defibrillators, neurostimulators, cochlear implants, certain implanted automated injection systems (insulin pumps), vascular intracerebral ferromagnetic clips, certain systems to regulate intravascular temperature, myopia requiring the patients to wear spectacle, history of stroke or transient ischemic attack (TIA), metallic foreign body, in particular intraocular or situated near high-risk zones (nervous system, vascular system), claustrophobia….

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: type 2 diabetics treated with GLP1 analogue<br> | Drug: Liraglutide<br> <br> |
| Active Comparator: Type 2 diabetics not treated with incretins<br> | Other: Observation alone<br> <br> |
| Other: Healthy subjects<br> | Other: Observation alone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modifications in wanting |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modifications in gustatory performance |  | Until 3 months | 
| Modifications in liking |  | Until 3 months | 
| Modifications in salivation following the presentation of foods |  | Until 3 months | 
| Modifications in optimal preferences for sweet and fatty tastes |  | Until 3 months | 
| Anthropometric modifications |  | Until 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI>27, Treatment with Liraglutide