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

NCT ID: NCT01599338

Last Updated: 2012-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-09-30

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.

Conditions

Type 2 Diabetes Mellitus; Overweight

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Liraglutide

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

Group Type: EXPERIMENTAL

Liraglutide

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Novonordisk (Puteaux, France)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Marie Claude Brindisi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie-Claude Brindisi, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon

Locations

CHU Dijon

Dijon, Bourgogne-Franche-Comté, France

Countries

France

Other Identifiers

2010-022618-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A100991-10

Identifier Type: -

Identifier Source: org_study_id