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

May 14, 2012
May 31, 2012
January 2011
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01599338 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients
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.

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Type 2 Diabetes Mellitus
  • Overweight
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)
Experimental: Liraglutide
Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).
Intervention: Drug: Liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01599338
A100991-10, 2010-022618-19
No
Marie Claude Brindisi, Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Dijon
Not Provided
Principal Investigator: Marie-Claude Brindisi, MD CHU Dijon
Centre Hospitalier Universitaire Dijon
May 2012

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