NCT02674893终止4 期
Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Modifications in wanting
研究概览
简要总结
This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.
Distribution in groups
- 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1)
- 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2)
- 30 healthy subjects (non-diabetics) (group 3)
This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
- •persons who have provided written informed consent
- •aged > 18 years
- •type 2 diabetes with HbA1C > 7%
- •overweight (BMI > 27)
- •normal renal function (creatinine clearance > 50ml/min)
- •patients to be treated with Liraglutide (patients with type 2 diabetes with HbA1C > 7.5% and overweight or obesity, whose current treatment is insufficient to control the diabetes).
- •CONTROL DIABETIC PATIENTS
- •persons who have provided written informed consent
- •aged > 18 years
- •type 2 diabetes with HbA1C > 7%
- •overweight (BMI > 27)
- •patients for whom treatment with Liraglutide is not indicated
- •normal renal function (creatinine clearance > 50ml/min)
- •HEALTHY SUBJECTS
- •persons who have provided written informed consent
- •aged > 18 years
排除标准
- •DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
- •type 1 diabetes
- •decompensated congestive heart failure
- •acute or chronic infection, progressive cancer, liver cirrhosis
- •ongoing treatment with antibiotics
- •chronic alcohol abuse (>4 glasses a day)
- •aversion to the products to be eaten or smelled
- •poor understanding of the cognitive tasks requested
- •treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs
- •persons without national health insurance cover
- •persons under guardianship
- •hypersensitivity to Liraglutide
- •pregnancy, breastfeeding
- •history of acute or chronic pancreatitis
- •calcitonin level at selection ≥ 50 ng/L
- •liver disease, defined by a level of alanine aminotransferase (ALAT) ≥ 2.5 times the upper limit of normal (ULN) for reference values
- •CONTROL DIABETIC PATIENTS
- •type 1 diabetes,
- •decompensated congestive heart failure,
- •acute or chronic infection, progressive cancer, liver cirrhosis,
- •ongoing treatment with antibiotics,
- •chronic alcohol abuse (> 4 glasses a day),
- •aversion to the products to be eaten or smelled,
- •poor understanding of the cognitive tasks requested,
- •treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs.
- •persons without national health insurance cover
- •persons under guardianship
- •HEALTHY SUBJECTS
- •diabetes (type I and II)
- •sensory disorders
- •decompensated congestive heart failure,
- •acute or chronic infection, progressive cancer, liver cirrhosis,
- •ongoing treatment with antibiotics,
- •chronic alcohol abuse (> 4 glasses a day),
- •aversion to the products to be eaten or smelled,
- •poor understanding of the cognitive tasks requested,
- •treatment interfering with olfactogustatory performance (psychotropic, anti-emetic, anti-ulcer drugs)
- •persons without national health insurance cover
- •persons under guardianship
- •contra-indications to MRI, notably, but not limited to: pace maker, implantable cardiac defibrillators, neurostimulators, cochlear implants, certain implanted automated injection systems (insulin pumps), vascular intracerebral ferromagnetic clips, certain systems to regulate intravascular temperature, myopia requiring the patients to wear spectacle, history of stroke or transient ischemic attack (TIA), metallic foreign body, in particular intraocular or situated near high-risk zones (nervous system, vascular system), claustrophobia….
研究组 & 干预措施
type 2 diabetics treated with GLP1 analogue
Experimental
干预措施: Liraglutide (Drug)
Type 2 diabetics not treated with incretins
Active Comparator
干预措施: Observation alone (Other)
Healthy subjects
Other
干预措施: Observation alone (Other)
结局指标
主要结局
Modifications in wanting
时间窗: Up to 3 months
次要结局
- Modifications in gustatory performance(Until 3 months)
- Modifications in liking(Until 3 months)
- Modifications in salivation following the presentation of foods(Until 3 months)
- Anthropometric modifications(Until 3 months)
- Modifications in optimal preferences for sweet and fatty tastes(Until 3 months)
研究者
研究点 (1)
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