|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 28, 2006 | ||||
| Last Updated Date | September 18, 2009 | ||||
| Start Date ICMJE | October 2003 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Amount of food consumed after administration of CCK (measured upon study completion) [ Time Frame: Measured at Day 4 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Amount of food consumed after administration of CCK (measured upon study completion) | ||||
| Change History | Complete list of historical versions of study NCT00308776 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa | ||||
| Official Title ICMJE | Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa | ||||
| Brief Summary | This study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa. |
||||
| Detailed Description | Bulimia Nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Cholecystokinin (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 CCK, which may contribute to their binge eating behavior. This study will determine the effectiveness of administrating a dose of CCK during a binge eating episode in reducing this eating behavior in people with BN. This study will enroll females with BN and healthy females without BN. Interested participants will first report to the study site for an interview about their feelings on their eating habits. If eligible, participants will report to the study site at 9 A.M. on 4 days. Upon arrival, they will receive a standardized breakfast of apple juice and an English muffin with butter. Participants will then return 2.5 hours later to start an IV and begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of either saline or saline plus CCK. Participants will then be given a meal of macaroni and beef. They will be alone in the room while eating, but will be monitored by TV camera. Nothing, however, will be taped or recorded. A tape recording will be used to instruct participants when to begin eating. Participants will be instructed to either eat until an assistant returns to the room, or eat as much as they can. Participants will also fill out questionnaires before and after each meal, and sometimes during a meal. The amount of food consumed after an infusion with CCK will be assessed upon study completion. For information on related studies, please follow these links: http://clinicaltrials.gov/show/NCT00307190 http://clinicaltrials.gov/show/NCT00304187 |
||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00308776 | ||||
| Responsible Party | B. Timothy Walsh, MD, New York State Psychiatric Institute | ||||
| Study ID Numbers ICMJE | R01 MH042206-03, DATR A2-AID | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||