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Completed

NCT Number: NCT01599338

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Feeding Behavior Food Preferences Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon

Dijon, Bourgogne-Franche-Comté, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

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.

Other names: Novonordisk (Puteaux, France)

Primary outcomes

  1. Change in liking and wanting for protein, lipid and glucid foods

    Time frame: 3 months

  2. Change in sensory specific satiety for protein, lipid and glucid foods

    Time frame: 3 months

  3. Change in gustative detection thresholds for sweet, bitter and salty tastes

    Time frame: 3 months

  4. Change in appetite, desire to eat, pleasure in eating

    Time frame: 3 months

Secondary outcomes

  1. Change in body mass composition (Dual Energy XRay Absorptiometry)

    Time frame: 3 months

  2. Change in plasma ghrelin, leptin, and HbA1c levels

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 16, 2012
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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