- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471806
Dopamine Release to Food Reward in Bulimia Nervosa
Dopamine Release to Food Reward in Bulimia Nervosa: an [18F]-Fallypride PET/MR Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bulimia nervosa is a psychiatric eating disorder characterized by recurrent episodes of binge eating, followed by inappropriate compensatory behaviour. It is associated with a high disease burden and high rates of medical and psychiatric comorbidities. Only 50% of patients achieve long-term remission, indicating the need for a better understanding of the pathophysiology which can guide the development of new treatment options.
There are strong indications for an involvement of the brain's dopaminergic reward system in Bulimia Nervosa, such as the presence of elevated craving for rewarding food and poorer impulse control. However, there is no clear evidence on the exact involvement of the reward system nor direct evidence of abnormal dopamine responses to food reward. Therefore, the current study will assess dopamine release and related brain activity to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. Specifically, the investigators will compare dopamine release in Bulimia Nervosa patients to healthy controls, and assess the effect of successful treatment on the food reward response. To this end, 20 Bulimia Nervosa patients will participate in one PET-MR scan before the start of inpatient treatment and in a second PET-MR scan at the end of inpatient treatment. Additionally, PET-MR scans will be obtained from a group of 20 healthy control participants.
All scan session will measure dopamine release to a combination of anticipatory (viewing high-calorie food images) and consummatory (drinking sips of chocolate milkshake) food reward and will be conducted in a fasted state. The scan sessions will consist of four blocks with a duration of 45 minutes each and 15 minute breaks in between. The first three blocks represent the 'control condition' and the fourth block the 'food reward condition'. During both sessions, blood samples will be collected at several time points to assess levels of metabolic hormones and their relation to food-induced dopamine release.
This study aims to improve our understanding of the disease process underlying Bulimia Nervosa and to enable the identification of new and specific treatment targets at multiple levels of the gut-brain axis, including the dopamine system in the brain but also metabolic hormones and the interactions between both. Additionally, the results may have the potential to guide the optimisation of behavioural treatment approaches with a stronger focus on aberrant reward system responses.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- Universitaire Ziekenhuizen Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patients with Bulimia Nervosa:
Inclusion Criteria:
- Diagnosed with Bulimia Nervosa based on DSM-5 criteria;
- Admission for inpatient treatment;
- Female (on hormonal contraception);
- Dutch-speaking;
- Right-handed;
- Body Mass Index (BMI) of 18.5 - 25 kg/m².
Exclusion Criteria:
- Medical, neurological or other psychiatric disorders;
- Use of psychotropic medication in past 6 months;
- Use of cannabis or other drugs of abuse in past 12 months;
- Lactose-intolerance or food allergies;
- Vegetarian diet;
- Smoking;
- Consumption of more than 7 alcoholic units per week;
- Exposure to a significant amount of ionizing radiation in past 12 months;
- Claustrophobia;
- Contra-indications for Magnetic Resonance Imaging;
- Pregnancy.
Healthy control participants:
Inclusion Criteria:
- Healthy females (on hormonal contraception);
- Dutch-speaking;
- Right-handed;
- Stable body weight with BMI of 18.5 - 25 kg/m².
Additional Exclusion Criteria:
- Any psychiatric disorders;
- Emotional or restraint eating behaviour.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bulimia Nervosa patients
Bulimia Nervosa patient group: Assessment of dopamine release to food reward at baseline (before treatment) and to food reward after treatment.
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Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at baseline.
Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at the end of inpatient treatment.
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Experimental: Healthy controls
Healthy control group: Assessment of dopamine release to food reward at baseline, for comparison with Bulimia Nervosa patients.
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Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at baseline.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dopamine release to food reward in Bulimia Nervosa patients compared to healthy controls
Time Frame: Continuously over 225 minutes after onset scanning; at baseline (before onset treatment of patients)
|
Comparison of dopamine release to food reward between Bulimia Nervosa patients and healthy controls.
Dopamine release is defined as changes in [18F]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.
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Continuously over 225 minutes after onset scanning; at baseline (before onset treatment of patients)
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Change in dopamine release to food reward in Bulimia Nervosa patients before and after treatment
Time Frame: Continuously over 225 minutes after onset scanning; before and after inpatient treatment
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Comparison of dopamine release to food reward before and after inpatient treatment for Bulimia Nervosa.
Dopamine release is defined as changes in [18F]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.
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Continuously over 225 minutes after onset scanning; before and after inpatient treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite measure of metabolic hormone levels
Time Frame: 5 minutes before onset scanning and 45, 105, 165, 180, 195, 210 and 225 minutes after onset scanning
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Correlation between dopamine response to food reward and (changes in) metabolic hormone levels (ghrelin, motilin, glucagon-like peptide 1, peptide tyrosine tyrosine, leptin, and insulin)
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5 minutes before onset scanning and 45, 105, 165, 180, 195, 210 and 225 minutes after onset scanning
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S60362-BN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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