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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in appetite, desire to eat, pleasure in eating
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients
- •with glycemic unbalance despite anti-diabetic treatments and
- •overweight (BMI > 25 kg/m²)
排除标准
- •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
研究组 & 干预措施
Liraglutide
Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change in appetite, desire to eat, pleasure in eating
时间窗: 3 months
Change in liking and wanting for protein, lipid and glucid foods
时间窗: 3 months
Change in sensory specific satiety for protein, lipid and glucid foods
时间窗: 3 months
Change in gustative detection thresholds for sweet, bitter and salty tastes
时间窗: 3 months
次要结局
- Change in body mass composition (Dual Energy XRay Absorptiometry)(3 months)
- Change in plasma ghrelin, leptin, and HbA1c levels(3 months)
研究者
Marie Claude Brindisi
MD
Centre Hospitalier Universitaire Dijon