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The effect of lidocaine infusion on ad libitum food intake and satiety in healthy volunteers - Lidocaine infusion and food intake
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 64（—）
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)
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 week)
- •* Self-admitted HIV-positive state
- •* Any food allergy
- •* Not able to eat a chili con carne meal.
研究者
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