Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008371
Recruitment Status : Withdrawn (No recruitment)
First Posted : November 5, 2009
Last Update Posted : May 22, 2013
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Society of Nuclear Medicine
Information provided by:
Medical University of South Carolina

Tracking Information
First Submitted Date November 3, 2009
First Posted Date November 5, 2009
Last Update Posted Date May 22, 2013
Study Start Date October 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2009)
  • Cholecystokinin serum level [ Time Frame: fasting- state, then at time points 30, 60 and 120 minutes post-meal ]
  • Oxytocin serum bioassay [ Time Frame: fasting-state, and then at time points of 30, 60 and 120 minutes post-meal ]
  • Gastric Emptying time [ Time Frame: calculated at time points 0.5, 1,2,3 and 4 hours post-meal ]
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 3, 2009)
Mini International Neuro-psychiatric Interview (MINI) [ Time Frame: once within 30 days of the scan ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity.
Official Title CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample, patients of a weight management clinic and patients of Medical University of South Carolina
Condition
  • Obesity
  • Gastric Emptying
  • Anxiety
  • Depression
  • Panic Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Obese
    Healthy obese subjects
  • Non-obese
    Healthy non-obese subjects
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 21, 2013)
0
Original Estimated Enrollment
 (submitted: November 3, 2009)
14
Actual Study Completion Date March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01008371
Other Study ID Numbers 19449
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kelly Holes-Lewis, M.D., Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators
  • National Institutes of Health (NIH)
  • Society of Nuclear Medicine
Investigators
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
PRS Account Medical University of South Carolina
Verification Date July 2010