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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Marie Claude Brindisi, Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT01599338

First received: May 14, 2012

Last updated: May 31, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 14, 2012

Last Updated Date

May 31, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in liking and wanting for protein, lipid and glucid foods [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in sensory specific satiety for protein, lipid and glucid foods [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in gustative detection thresholds for sweet, bitter and salty tastes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in appetite, desire to eat, pleasure in eating [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01599338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in body mass composition (Dual Energy XRay Absorptiometry) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in plasma ghrelin, leptin, and HbA1c levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes Mellitus
Overweight

Intervention ^ICMJE

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.

Other Name: Novonordisk (Puteaux, France)

Study Arm (s)

Experimental: Liraglutide

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

Intervention: Drug: Liraglutide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetic patients

with glycemic unbalance despite anti-diabetic treatments and
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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01599338

Other Study ID Numbers ^ICMJE

A100991-10, 2010-022618-19

Has Data Monitoring Committee

Responsible Party

Marie Claude Brindisi, Centre Hospitalier Universitaire Dijon

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire Dijon

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marie-Claude Brindisi, MD

CHU Dijon

Information Provided By

Centre Hospitalier Universitaire Dijon

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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