Eating Disorders Clinical Trial
Official title:
Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
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.
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
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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