NCT00914212已完成1 期
A Functional Magnetic Resonance Imaging (fMRI) Study of the Reproducibility and the Effect of Sibutramine During Fasted and Fed Conditions in Healthy Overweight and Obese Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
研究概览
简要总结
This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a male between 18 and 45 years of age
- •Subject has a body mass index (BMI) between 28 and 35 kg/m^2
- •Subject does not weigh more than 140 kg (309 lbs) at the screening visit
- •Subject is right-handed
- •Subject is a non-smoker
- •Subject is in generally good health
- •Subject has normal or corrected to normal vision
排除标准
- •Subject works a night shift within 3 days of each treatment visit
- •Subject has permanent cosmetic or metallic objects in his body
- •Subject has attention deficit hyperactivity disorder (ADHD)
- •Subject has or had sleep apnea
- •Subject has a history of neurological disorders
- •Subject has a history of any clinically significant disease or condition
- •Subject is vegan or vegetarian
- •Subject has a history of eating disorders
- •Subject has had previous bariatric surgery
研究组 & 干预措施
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
时间窗: Day 1
次要结局
- Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo(Day 1)
- Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs(Day 1)
- Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs(Day 1)
- Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs(Day 1)
- AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs(Day 1)
- Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs(Day 1)
- rCBF during the fed condition with placebo or sibutramine in the six ROIs(Day 1)
研究者
相似试验
已完成
不适用
Appetite-Related Brain Activity in Women With Anorexia NervosaEating DisordersAnorexia NervosaNCT00344656New York State Psychiatric Institute15
已完成
不适用
Satiety Effects on the Neural Valuation of FoodFastingFedNCT01721187Duke-NUS Graduate Medical School60
已完成
不适用
Brain Activation in Response to Appetitive Cues Pre- and Post- Bariatric SurgeryObesityNCT01590914New York Obesity and Nutrition Research Center120
已完成
不适用
Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's DiseaseEssential TremorObsessive Compulsive DisorderDystoniaParkinson DiseaseNCT01809613Mayo Clinic88
终止
不适用
Study of New Magnetic Resonance MethodsHealthyNCT00001844National Institutes of Health Clinical Center (CC)99