NCT01008371撤回不适用
CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cholecystokinin serum level
研究概览
简要总结
The purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair the ability to feel full and which therefore, may lead to obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18 to 65 years of age.
- •Obese Subjects with BMI >
- •Normal weight subjects with BMI = 18.5-24.9
排除标准
- •Age younger than 18 years and over 65 years of age.
- •Current use of narcotics or morphine
- •Previous gastric surgery
- •Presence of the following disorders that are known to cause functional gastric stasis syndromes: Diabetes Mellitus, Hypothyroidism, Progressive Systemic Sclerosis, Systemic Lupus Erythematosus, Dermatomyositis, Familial Dysautonomia, Pernicious Anemia, Bulbar poliomyelitis, Amyloidosis, Gastric Ulcer, Post-vagotomy, Tumor-associated gastroparesis, Fabry disease, Myotonic Dystrophy, Post-operative ileus, Gastroenteritis.
- •Presence of the following disorders that are known to cause delayed gastric emptying: peptic ulceration, recent surgery, pyloric hypertrophy, post-radiotherapy, ileus, anorexia nervosa, acute viral infections.
- •Presence of the following disorders that are known to cause rapid gastric emptying: Pyloroplasty, Hemigastrectomy, Duodenal ulcer, Gastrinoma (Zollinger-Ellison syndrome), Hyperthyroidism
- •Current use of Thyroxine as it is known to cause rapid gastric emptying
- •Current or recent (within the last 2 weeks) use of anti-spasmodics or pro-kinetic medications.
- •Current use of Hyperalimentation
- •Presence of any metabolic disorder, such as: hyperglycemia, acidosis, hypokalemia, hypercalcemia, hepatic coma or myxedema.
- •Current use of estrogen or progesterone
- •Current use of the following drugs that are known to delay gastric emptying: Nifedipine, beta-adrenergic agonists, Isoproterenol, Theophylline, Sucralfate, anticholinergics, Levodopa, diazepam, tricyclic antidepressants, phenothiazine, Progesterone, oral contraceptives, alcohol, nicotine, opiates.
- •Allergy to eggs or wheat.
- •Pregnancy.
结局指标
主要结局
Cholecystokinin serum level
时间窗: fasting- state, then at time points 30, 60 and 120 minutes post-meal
Oxytocin serum bioassay
时间窗: fasting-state, and then at time points of 30, 60 and 120 minutes post-meal
Gastric Emptying time
时间窗: calculated at time points 0.5, 1,2,3 and 4 hours post-meal
Perception of fullness using visual analog scales
时间窗: fasting-state, and then at time points of every half hour post-meal through completion of the scan
次要结局
- Mini International Neuro-psychiatric Interview (MINI)(once within 30 days of the scan)
研究者
研究点 (1)
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