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

May 21, 2013 updated by: Medical University of South Carolina

CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample, patients of a weight management clinic and patients of Medical University of South Carolina

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Obese
Healthy obese subjects
Non-obese
Healthy non-obese subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cholecystokinin serum level
Time Frame: fasting- state, then at time points 30, 60 and 120 minutes post-meal
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
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
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
fasting-state, and then at time points of every half hour post-meal through completion of the scan

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini International Neuro-psychiatric Interview (MINI)
Time Frame: once within 30 days of the scan
once within 30 days of the scan

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19449

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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