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Recruitment Status : Withdrawn (No recruitment)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

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

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

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

Original Estimated Enrollment

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

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

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