- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00308776
Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa
Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Patients with BN:
- Meets DSM-IV criteria for BN
- BN duration of more than 1 year
- Self-induces vomiting
- Weighs between 80 and 120% of ideal body weight
Exclusion Criteria for Patients with BN:
- Significant medical illness
- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR criteria
- 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 the study procedures
- At risk for suicide, as defined by the expression of an imminent plan or attempt within the 6 months prior to study entry
- Currently taking psychotropic medications or medications that affect gastrointestinal function
- Moderate to severe depression, as defined by a score of greater than 28 on the Hamilton Depression Rating Scale
- Drug or alcohol abuse within the 3 months prior to study entry
- Pregnant, planning to become pregnant, or lactating
- Body mass index (BMI) of less than 18 (underweight)
Inclusion Criteria for Normal Weight Controls:
- No current or past psychiatric history
- No history of binge eating or vomiting
- 80-120% of ideal body weight
Exclusion Criteria for Normal Weight Controls:
- Significant medical illness
- Current psychotropic medications and current medications that affect GI function
- Drug or alcohol abuse in last 3 months
- Pregnancy, planning to become pregnant or laction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cholecystokinin
Participants will receive intravenous saline plus cholescystokinin.
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Participants will 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 saline plus CCK.
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Placebo Comparator: Saline
Participants will receive intravenous saline only.
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Participants will 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 saline only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of food consumed after administration of CCK (measured upon study completion)
Time Frame: Measured at Day 4
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Measured at Day 4
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: B. Timothy Walsh, MD, New York State Psychiatric Institute at Columbia University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #4736
- DATR A2-AID (NIH Adult Translational Research and Treatment Development)
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.
Clinical Trials on Bulimia Nervosa
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
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Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
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Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
-
Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
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Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
University Health Network, TorontoKlarman Family FoundationCompletedAnorexia Nervosa | Bulimia Nervosa
-
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