An interventional study of Neurofunctional characterization of emotional regulation (fMRI) in Obesity and Binge-Eating Disorder, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by CHU de Reims · Not applicable, Interventional, and Basic science
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Among 475 studies in Obesity with a site in France — 111 open to participants now, 127 under way, 25 of them phase 3. Obesity · France.
Among the 475 studies in Obesity with a site in France, this one is the 163rd largest by planned enrollment of the 354 interventional ones that give a count, is one of 27 that started in 2022, is one of 258 with no phase, reaches primary completion later than 14 of the 126 other live ones, and was the 332nd registered.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
Browse Obesity studies →111 of the 475 studies in Obesity with a site in France are open now. Recruiting first, the newest first:
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques · Sites in France
Ages 50–75
AstraZeneca · Sites in France, United States, Argentina and 13 more countries
Ages 18+
Novo Nordisk A/S · Sites in France, United States, Belgium and 7 more countries
Ages 18+
Hospices Civils de Lyon · Sites in France
Ages 18–75
Universite du Littoral Cote d'Opale · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
475 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 21 · Phase 3 61 · Phase 4 14
First in 2001; this study’s year is marked. 27 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 67 across 9,016 interventional studies indexed under Obesity.
Median enrollment 80 across the 354 interventional studies, 133 across the 121 observational. Of the 295 that completed or were terminated, 16 (5%) have results posted.
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76 of 475 have an industry lead sponsor. The 10 most frequent:
CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.
CHU de Reims has 4 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
30 of the studies in Obesity with a site in France that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT03516968Phase 3Hospices Civils de LyonMonthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents | 2027-03 |
| NCT07220642Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | 2027-05-11 |
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
Add all 30 to your calendar (.ics) → With an account.
Among the 475 studies in Obesity with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. The purpose of this study is to fill this gap by comparing the neurofunctional profiles of emotion regulation between patients suffering from obesity, with or without BED and healthy participants during the performance of emotion regulation tasks. Results may help to understand the neural bases of the impairments observed in patients with obesity, with or without BED, which may in turn help to propose, in the long term, potential new therapeutic approaches.
Obesity is a major public health problem and frequently associated with Binge eating disorder (BED) in patients considered for weight loss surgery and seems to influence their outcome critically. It may be due, in part, to an ineffective or a maladaptive emotional regulation. Emotion regulation is the ability to exert control over one's own emotional state. The relative absence of this ability would indicate the presence of difficulties in emotion regulation, or an emotion dysregulation. Individuals with disordered eating may have a greater vulnerability to use maladaptive emotion regulation strategies. In the eating behaviours, an emotion dysregulation can cause weight gain that can lead to overweight or obesity. Accordingly, patients suffering from obesity, and with BED may have a greater vulnerability to use maladaptive emotion regulation strategies. However, few studies have investigated the neurofunctional profiles of emotion regulation in patients suffering from obesity with and without BED and seeking bariatric surgery.
The aim of the study is to explore the neural correlates of emotion regulation in patients suffering from obesity, with or without BED, in comparison with those of healthy participants. We also aim to describe the relationship between the neural correlates, eating behaviours and assessed psychological profiles.
Group 1: Patients suffering from obesity, seeking bariatric surgery, and with BED.
Inclusion criteria:
Exclusion criteria:
Group 2: Patients suffering from obesity, seeking bariatric surgery, and without BED.
Inclusion criteria:
Exclusion criteria:
Group 3: Healthy participants.
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Neurofunctional characterization of emotional regulation (fMRI)
Behavioral: Neurofunctional characterization of emotional regulation (fMRI)
Behavioral: Neurofunctional characterization of emotional regulation (fMRI)
Investigation of neurofunctional characterization of emotional regulation and its links with the eating behaviours of patients suffering from obesity using a comprehensive, clinical, and cognitive assessment and task-based MRI exams.
fMRI activations during an emotional regulation task (a cognitive reappraisal task)
The participant either reappraises or passively watches negative or neutral pictures and rates his affect (visual analogue scale: 0 to 10, high scores mean negative feelings).
Time frame: Day 0
fMRI activations during the inhibition of an ongoing motor response under an emotional condition (emotional stop signal task)
The participant is presented with a series of images comprised of neutral, positive, and negative categories and is instructed to categorize the images according to their valence (Go trials). Some trials include a stop signal indicating that the participant should inhibit his behavioral response and associated emotional reaction (Stop trials).
Time frame: Day 0
fMRI activations during the performance of an emotion regulation task (an emotional Stroop task)
The participant is asked to count how many numbers are presented on the screen. Numbers may match the value of the number (congruent condition) or not (incongruent condition). The numbers are preceded by emotional stimuli (negative, positive, neutral). The participant also views the emotional stimuli pictures without counting numbers (view condition).
Time frame: Day 0
Description of eating behaviours: Binge eating
The Binge Eating Scale (BES) is a 16-item self-administered questionnaire used to assess the presence of binge eating behavior indicative of an eating disorder. Eight items describe behavioral manifestations (for example, eating fast or consuming large amounts of food) and eight items on associated feelings and cognitions (for example, fear of not stopping eating). Each item has a response range from 0 to 3 points (0 = no severity of the BES symptoms, 3 = serious problems on the BES symptoms). Marcus et al. (1988) created a range of scores for the BES from 0 to 46 points: a score of less than 17 points indicates minimal binge eating (BE) problems; a score between 18 and 26 points indicates moderate BE problems, and a score of more than 27 points indicates severe BE problems. We consider binge eating as a categorical variable (significant binge eating if BES score ≥18).
Time frame: Day 0
Description of eating behaviours: Emotional eating, external eating, restraint eating
The Dutch Eating Behavior Questionnaire (DEBQ) is administered using the French version to assess three components of eating behavior: emotional, external, and restrained eating. It is a self-report measure that contains 33 items. Thirteen items assess emotional eating, 10 items assess external eating, and 10 items assess restrained eating. Each item is rated on a 5-point Likert scale. Higher scores on each dimension mean worse eating behaviors.
Time frame: Day 0
Description of eating behaviours: Bulimic symptomatology
The Bulimic Investigatory Test, Edinburgh (BITE) is a self-report questionnaire used to evaluate the presence and severity of bulimic symptomatology. It is composed of 33 items divided into two different subscales: a symptom subscale (30 items) and a severity subscale (3 items). Henderson and Freeman (1987) considered a BITE score under 10 points as indicative of no problem with eating behavior, a score between 10 and 20 points as indicative of abnormal eating patterns (from 15 to 20 points warns us of the presence of a possible subthreshold bulimia nervosa), and a score higher than 20 points constitutes altered eating patterns with a possible bulimia nervosa.
Time frame: Day 0
Description of psychological profiles (emotional, cognitive and personality): Emotion regulation
The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire. It assesses six different aspects of emotional regulation including non-acceptance of emotional responses (Non-Acceptance), difficulty engaging in goal-directed behavior (Goals), impulse control difficulties (Impulse), lack of emotional awareness (Awareness), limited access to emotional regulation strategies (Strategies), and lack of emotional clarity (Clarity). Higher scores on each dimension indicate greater emotion dysregulation symptoms.
Time frame: Day 0
Description of psychological profiles (emotional, cognitive and personality): Depression severity
Depression severity is assessed with the shortened Beck Depression Inventory (BDI). This is a widely used self-report scale consisting of 13 items, which has been validated in French. The total score is obtained by adding the scores of the 13 items and ranges from 0 to 39, with higher scores indicating greater depression symptoms.
Time frame: Day 0
Description of psychological profiles (emotional, cognitive and personality): Anxiety severity
Anxiety severity is assessed with the Spielberger State-Trait Inventory (STAI) which is a 40-item scale, using a 4-point Likert scale for each item. This scale was used to measure both trait anxiety (how dispositionally anxious a person is across time and situations) and state anxiety (how anxious a person is feeling at a particular moment). Higher scores indicate greater anxiety symptoms.
Time frame: Day 0
Description of psychological profiles (emotional, cognitive and personality): Impulsivity
We use the UPPS-P Impulsive Behavior Scale to assess the facets of impulsivity, i.e., Negative Urgency, Positive Urgency, (lack of) Premeditation, (lack of) Perseverance, and Sensation Seeking. This shortened version (20 items) has 4 items per scale, and each item is responded to on a 4-point Likert-type scale. Higher scores on each scale indicate greater impulsivity symptoms. This self-report scale has received endorsement from the National Institutes of Health's (NIH) PhenX Toolkit as the recommended self-report measure of impulsigenic traits.
Time frame: Day 0
Started Jul 2022 (actual). Primary completion is estimated for Jul 2025, 36 months after the start.
Of 3,685 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 36 months is above that.
Counting every sponsor, half of 3,848 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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