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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599338
• Other study ID #: A100991-10
• Secondary ID: 2010-022618-19
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: May 31, 2012
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Liraglutide
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.

Locations

Country	Name	City	State
France	CHU Dijon	Dijon	Bourgogne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liking and wanting for protein, lipid and glucid foods		3 months	No
Primary	Change in sensory specific satiety for protein, lipid and glucid foods		3 months	No
Primary	Change in gustative detection thresholds for sweet, bitter and salty tastes		3 months	No
Primary	Change in appetite, desire to eat, pleasure in eating		3 months	No
Secondary	Change in body mass composition (Dual Energy XRay Absorptiometry)		3 months	No
Secondary	Change in plasma ghrelin, leptin, and HbA1c levels		3 months	No