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

Primary Purpose

Type 2 Diabetes Mellitus, Overweight

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring Liraglutide, GLP-1 analogue, Food preference, Gustative perception, Liking, wanting, T2DM, body mass composition, leptin, ghrelin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Dijon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liraglutide

Arm Description

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

Outcomes

Primary Outcome Measures

Change in liking and wanting for protein, lipid and glucid foods
Change in sensory specific satiety for protein, lipid and glucid foods
Change in gustative detection thresholds for sweet, bitter and salty tastes
Change in appetite, desire to eat, pleasure in eating

Secondary Outcome Measures

Change in body mass composition (Dual Energy XRay Absorptiometry)
Change in plasma ghrelin, leptin, and HbA1c levels

Full Information

First Posted
May 14, 2012
Last Updated
May 31, 2012
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01599338
Brief Title
Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight
Keywords
Liraglutide, GLP-1 analogue, Food preference, Gustative perception, Liking, wanting, T2DM, body mass composition, leptin, ghrelin

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Novonordisk (Puteaux, France)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in liking and wanting for protein, lipid and glucid foods
Time Frame
3 months
Title
Change in sensory specific satiety for protein, lipid and glucid foods
Time Frame
3 months
Title
Change in gustative detection thresholds for sweet, bitter and salty tastes
Time Frame
3 months
Title
Change in appetite, desire to eat, pleasure in eating
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in body mass composition (Dual Energy XRay Absorptiometry)
Time Frame
3 months
Title
Change in plasma ghrelin, leptin, and HbA1c levels
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Claude Brindisi, MD
Organizational Affiliation
CHU Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Dijon
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

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

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