Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity.

Study Overview
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Brief Summary
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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.

Official Title
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CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

Conditions
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Obesity, Gastric Emptying, Anxiety, Depression, Panic Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 18 to 65 years of age. Obese Subjects with BMI >40. Normal weight subjects with BMI = 18.5-24.9 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese<br>Healthy obese subjects | |
| Non-obese<br>Healthy non-obese subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholecystokinin serum level |  | fasting- state, then at time points 30, 60 and 120 minutes post-meal | 
| Oxytocin serum bioassay |  | fasting-state, and then at time points of 30, 60 and 120 minutes post-meal | 
| Gastric Emptying time |  | calculated at time points 0.5, 1,2,3 and 4 hours post-meal | 
| Perception of fullness using visual analog scales |  | fasting-state, and then at time points of every half hour post-meal through completion of the scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini International Neuro-psychiatric Interview (MINI) |  | once within 30 days of the scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Cholecystokinin, Oxytocin, Satiety, Gastric emptying, Anxiety, Depression, Panic Disorder