EUCTR2016-001900-47-NL进行中（未招募）1 期
The effect of lidocaine infusion on ad libitum food intake and satiety in healthy volunteers - Lidocaine infusion and food intake
Maastricht University Medical Centre +0 个研究点目标入组 35 人开始时间: 2017年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Based on medical history and previous examination, no
- •gastrointestinal complaints can be defined.
- •Age between 18 and 50 years. Several studies (see introduction)
- •showed a difference in response to a meal between young and elderly
- •people. Inclusion of elderly could interfere with the outcome of this
- •study. Goal of this study is to investigate whether a difference in food
- •intake can be found after intragastric infusion of a local anaesthetic. For
- •this proof of concept study we therefore choose to include healthy male
- •volunteers with a maximum age of 50 years. This study will include
- •healthy male subjects.
- •BMI between 20 and 25 kg/m2)
- •Weight stable over at least the last 6 months (=5% weight change)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Females, because of their hormonal cycle and the possible influence
- •of these hormones on eating behaviour.
- •History of severe cardiovascular, respiratory, urogenital,
- •gastrointestinal/hepatic, haematological/immunologic, HEENT (head,
- •ears, eyes, nose, throat), dermatological/connective tissue,
- •musculoskeletal, metabolic/nutritional, endocrine,
- •neurological/psychiatric diseases, allergy, major surgery and/or
- •laboratory assessments which might limit participation in or completion
- •of the study protocol. The severity of the disease (major interference
- •with the execution of the experiment or potential influence on the study
- •outcomes) will be decided by the principal investigator.
- •Use of amiodaron, because of the cardiotoxicity (in combination with
- •lidocaine).
- •Use of beta blockers, cimetidine and norepinephrine (synergetic
- •effect on the action of Lidocaine).
- •Other use of medication, which could interfere with the outcome of
- •the study. This will be decided by the principal investigator.
- •Administration of investigational drugs or participation in any
- •scientific intervention study which may interfere with this study (to be
- •decided by the principle investigator), in the 90 days prior to the study
- •Major abdominal surgery interfering with gastrointestinal function
- •(uncomplicated appendectomy, cholecystectomy and hysterectomy
- •allowed, and other surgery upon judgement of the principle investigator)
- •Dieting (medically prescribed, vegetarian, diabetic, macrobiological,
- •biological dynamic)
- •Excessive alcohol consumption (>20 alcoholic consumptions per
- •Self-admitted HIV-positive state
- •Any food allergy
- •Not able to eat a chili con carne meal.
研究者
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