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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Overweight
Drug: Liraglutide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01599338

Locations
France
CHU Dijon
Dijon, Bourgogne, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Marie-Claude Brindisi, MD CHU Dijon
  More Information

No publications provided

Responsible Party: Marie Claude Brindisi, MD, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01599338     History of Changes
Other Study ID Numbers: A100991-10, 2010-022618-19
Study First Received: May 14, 2012
Last Updated: May 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire Dijon:
Liraglutide
GLP-1 analogue
Food preference
Gustative perception
Liking
wanting
T2DM
body mass composition
leptin
ghrelin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 01, 2014