Clinical trial NCT01008371: Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity.
Official title: CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Gastric Emptying
Anxiety
Depression
Panic Disorder
Keywords: Obesity
Cholecystokinin
Oxytocin
Satiety
Gastric emptying
Anxiety
Depression
Panic Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Society of Nuclear Medicine
First posted: 2009-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, patients of a weight management clinic and patients of 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cholecystokinin serum level
timeFrame: fasting- state, then at time points 30, 60 and 120 minutes post-meal
measure: Oxytocin serum bioassay
timeFrame: fasting-state, and then at time points of 30, 60 and 120 minutes post-meal
measure: Gastric Emptying time
timeFrame: calculated at time points 0.5, 1,2,3 and 4 hours post-meal
measure: Perception of fullness using visual analog scales
timeFrame: fasting-state, and then at time points of every half hour post-meal through completion of the scan
Secondary outcomes:
measure: Mini International Neuro-psychiatric Interview (MINI)
timeFrame: once within 30 days of the scan
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kelly A Holes-Lewis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Thomas W Uhde, M.D.
role: STUDY_CHAIR
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