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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Overweight
• Interventions: Drug: Liraglutide

• Registration Number: NCT01599338
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-09
• Status Verified: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liraglutide	Liraglutide	Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).

Primary Outcome Measures

Name	Time	Method
Change in appetite, desire to eat, pleasure in eating	3 months
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

Secondary Outcome Measures

Name	Time	Method
Change in body mass composition (Dual Energy XRay Absorptiometry)	3 months
Change in plasma ghrelin, leptin, and HbA1c levels	3 months

Trial Locations

Locations (1)

CHU Dijon; 🇫🇷 Dijon, Bourgogne, France