Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 主要终点
- Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
研究概览
简要总结
In this study, the investigators aimed at evaluating the role of motilin in the regulation of food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers and is significantly increased in obese patients. Its role in food intake regulation might contribute to the pathogenesis of obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI < 30 kg/m² for lean volunteers
- •BMI > 30 kg/m² for obese volunteers
- •Subject is capable and willing to give informed consent
- •Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception
排除标准
- •Female volunteer is pregnant or breastfeeding
- •GI diseases, major abdominal surgery
- •Major psychiatric illnesses
- •Volunteers that use drugs affecting the GI tract or the central nervous system
- •Volunteers suffering from endocrine diseases such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
- •Volunteers that have undergone surgical procedure for weight loss
研究组 & 干预措施
Erythromycin
40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
干预措施: Erythromycin (Drug)
Placebo
a saline solution of 100 ml will be administered intravenously over a period of 20 min
干预措施: Saline (Drug)
结局指标
主要结局
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
时间窗: Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake
次要结局
- Frequency of food intake correlated with motilin plasma levels(Assessment will be done over a period of 5 hours)