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

Withdrawn

• Conditions: Obesity; Gastric Emptying; Anxiety; Depression; Panic Disorder

• Registration Number: NCT01008371
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-05
• Status Verified: 2010-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mini International Neuro-psychiatric Interview (MINI)	once within 30 days of the scan

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States