Hormone Release and Stomach Disturbances in People With Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00307190
First received: March 23, 2006
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

This study will determine whether the disturbances in cholecystokinin release and gastric emptying that occur in people with binge eating disorder are similar to those that occur in people with bulimia nervosa.


Condition
Binge Eating Disorder
Obesity
Eating Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postprandial Cholecystokinin Release and Gastric Emptying in Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Biospecimen Retention:   Samples Without DNA

Blood serum


Enrollment: 24
Study Start Date: October 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Binge Eating Disorder
Women with Binge Eating Disorder
Controls
Weight, age, and gender-matched control subjects

Detailed Description:

Binge Eating Disorder (BED) is a serious eating disorder that can occur in people of any weight, but occurs most frequently in people who are overweight. BED is characterized by the following eating behaviors: frequent episodes of eating large quantities of food in short periods of time; feeling out of control over one's eating behavior; feeling ashamed or disgusted by one's eating behavior; eating when not hungry; and eating in secret. BED is similar to Bulimia Nervosa (BN), in that binge eating is a characteristic of both disorders. However, people with BED do not purge after an episode of binge eating, and therefore often become overweight. The health risks of BED include those that are most commonly associated with clinical obesity. High blood pressure, high cholesterol levels, heart disease, diabetes mellitus, and gallbladder disease are all health problems that occur frequently in people with BED. CCK is a hormone that is released by the small intestine, and functions as a trigger for digestion and hunger suppression. People with BN often have disturbances in the release of cholecystokinin (CCK), which may contribute to their binge eating behavior. This study will determine whether the disturbances in CCK release and gastric emptying that occur in people with BED are similar to those that occur in people with BN.

Participants in this study will report to the study site on two non-consecutive days within a 2-week period for gastric emptying testing. On the day before the first study visit, participants will be instructed to eat a standardized dinner that does not include alcohol before 7 P.M., and not to eat or drink after 9 P.M. On the first day of testing, participants will lie in a semi-reclined position while drinking 600 ml of Ensure Plus. A gamma camera will be placed over the stomach to measure gastric emptying. In addition, a catheter will be inserted into the forearm of all participants for periodic blood testing throughout the process. On the second day of testing, participants will perform the same procedures, but the Ensure Plus will also contain a small amount of radioactive material so that gastric emptying can be tracked by the gamma camera. The testing procedure on each day will take approximately 90 minutes.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00308776

http://clinicaltrials.gov/show/NCT00304187

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy, obese women between ages 18 and 60 with and without Binge Eating Disorder

Criteria

Inclusion Criteria:

For all participants:

  • Obese (body mass index (BMI) greater than 35 kg/m2)

For participants with BED:

  • Meets DSM-IV criteria for BED
  • BED duration of at least 1 year

For healthy participants:

  • Weight close to that of participants with BED

Exclusion Criteria for all participants:

  • Current or past diagnosis of BN, or any binge eating or self-induced vomiting
  • Significant medical illness
  • Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
  • Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
  • History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures
  • At risk for suicide
  • Currently taking psychotropic medication or medication that is known to affect appetite or gastric functioning
  • History of drug or alcohol abuse within the 3 months prior to study entry
  • Pregnant, planning to become pregnant, or lactating
  • Anemia
  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: NCT00307190

Locations
United States, New York
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: B. T. Walsh, MD New York State Psychiatric Institute at Columbia University Medical Center
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00307190     History of Changes
Other Study ID Numbers: #4735/#5797R, R01MH042206-04, DATR A2-AID
Study First Received: March 23, 2006
Last Updated: May 25, 2012
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
BED

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Hyperphagia
Mental Disorders
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014