NCT03228602终止不适用
Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Amplitude of the gustatory evoked potential
研究概览
简要总结
The aim of the study is to compare several parameters in three distinct groups of subjects: persons with obesity, persons with obesity and diabetes and persons with neither obesity nor diabetes:
- the electrical activity in response to a sweet solution, measured before and after a standard meal, using gustatory evoked potentials (recording explained below)
- blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin: measured in blood samples)
- levels of activity and quantity of an enzyme present in the saliva, amylase, which is able to break down ingested starch into several molecules of glucose.
All of these parameters will be correlated to determine whether the results are different in the 3 groups of subjects in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients who have provided written consent
- •Patients over 18 years old
- •Body Mass Index (BMI) <25 kg/m² for healthy volunteers and BMI≥30 kg/m² for obese subjects
- •Patients with type 2 diabetes for the group "obese diabetic subjects"
排除标准
- •Patients under guardianship
- •Patients without health insurance cover
- •Pregnant or breast-feeding women
- •Active smokers
- •Subjects with type 2 diabetes for the " healthy subjects " and " obese subjects ", subjects with type 1 diabetes for all groups
- •Subjects who do not speak French
- •Treatment that interferes with taste or acts on the central nervous system
- •Anti-diabetic treatment with GLP-1 analogues (Glucagon-like peptide 1) or SGLT2 (sodium-glucose cotransporter type 2)
- •Known hypersensitivity to the foods proposed in the study, or the paste used to fix the electrodes, or to paraffin wax or to the products tested (sucrose, glucose or starch for the gustatory evoked potentials and triangular tests)
研究组 & 干预措施
obese diabetic
Experimental
干预措施: Recording of GEP (Gustatory Evoked Potentials) (Other)
healthy subjects
Active Comparator
干预措施: Recording of GEP (Gustatory Evoked Potentials) (Other)
obese
Experimental
干预措施: Recording of GEP (Gustatory Evoked Potentials) (Other)
obese diabetic who are going to be operated on
Experimental
25 of a sleeve gastrectomy and 25 of a Y gastric bypass
干预措施: Recording of GEP (Gustatory Evoked Potentials) (Other)
结局指标
主要结局
Amplitude of the gustatory evoked potential
时间窗: Up to 10 days
Latency of the gustatory evoked potential
时间窗: Up to 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
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