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

This study has been withdrawn prior to enrollment.
(No recruitment)
Sponsor:
Collaborators:
Society of Nuclear Medicine
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01008371
First received: November 3, 2009
Last updated: May 21, 2013
Last verified: July 2010
  Purpose

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
Obesity
Gastric Emptying
Anxiety
Depression
Panic Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Cholecystokinin serum level [ Time Frame: fasting- state, then at time points 30, 60 and 120 minutes post-meal ] [ Designated as safety issue: No ]
  • Oxytocin serum bioassay [ Time Frame: fasting-state, and then at time points of 30, 60 and 120 minutes post-meal ] [ Designated as safety issue: No ]
  • Gastric Emptying time [ Time Frame: calculated at time points 0.5, 1,2,3 and 4 hours post-meal ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini International Neuro-psychiatric Interview (MINI) [ Time Frame: once within 30 days of the scan ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese
Healthy obese subjects
Non-obese
Healthy non-obese subjects

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008371

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
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
  More Information

Publications:

Responsible Party: Kelly Holes-Lewis, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01008371     History of Changes
Other Study ID Numbers: 19449
Study First Received: November 3, 2009
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Obesity
Cholecystokinin
Oxytocin
Satiety
Gastric emptying
Anxiety
Depression
Panic Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Obesity
Panic Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014