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

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ClinicalTrials.gov Identifier: NCT01008371
Recruitment Status : Withdrawn (No recruitment)
First Posted : November 5, 2009
Last Update Posted : May 22, 2013
Information provided by:

Study Description
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.

Condition or disease
Obesity Gastric Emptying Anxiety Depression Panic Disorder

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity
Study Start Date : October 2009
Primary Completion Date : March 2013
Study Completion Date : March 2013
Groups and Cohorts

Healthy obese subjects
Healthy non-obese subjects

Outcome Measures

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

Secondary Outcome Measures :
  1. Mini International Neuro-psychiatric Interview (MINI) [ Time Frame: once within 30 days of the scan ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample, patients of a weight management clinic and patients of Medical University of South Carolina

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008371

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
Society of Nuclear Medicine
Principal Investigator: Kelly A Holes-Lewis, M.D. Medical University of South Carolina
Study Chair: Thomas W Uhde, M.D. Medical University of South Carolina
More Information


Responsible Party: Kelly Holes-Lewis, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01008371     History of Changes
Other Study ID Numbers: 19449
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: July 2010

Keywords provided by Medical University of South Carolina:
Gastric emptying
Panic Disorder

Additional relevant MeSH terms:
Panic Disorder
Nutrition Disorders
Body Weight
Signs and Symptoms
Behavioral Symptoms
Anxiety Disorders
Mental Disorders