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| Tracking Information | |||||
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| First Received Date ICMJE | March 23, 2006 | ||||
| Last Updated Date | September 18, 2009 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00307190 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hormone Release and Stomach Disturbances in People With Binge Eating Disorder | ||||
| Official Title ICMJE | Postprandial Cholecystokinin Release and Gastric Emptying in Binge Eating Disorder | ||||
| Brief Summary | 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. |
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| 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 |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: For all participants:
For participants with BED:
For healthy participants:
Exclusion Criteria for all participants:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00307190 | ||||
| Responsible Party | B. Timothy Walsh, MD, The New York State Psychiatric Institute | ||||
| Study ID Numbers ICMJE | R01 MH042206-04, DATR A2-AID | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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