- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402031
Predicting Weight Loss After Pharmacological or Surgical Treatment in Patients With Obesity
May 11, 2026 updated by: Université Catholique de Louvain
Research of Predictive Factors of Weight Loss After Pharmacological or Surgical Treatment in Patients Suffering From Obesity
As with other nutritional strategies, the clinical response to bariatric surgery can be highly variable, with weight regain being a frequent occurrence.
Recent evidence on anti-obesity medication indicate similar inter-individual variability in clinical response.
Among multiples factors, co-occurrence of eating disorders such as binge eating disorder has been implicated in insufficient clinical response.
Improving our ability to predict how patients will respond to obesity treatment is necessary in order to tailor the care pathways we offer.
The mechanisms involved in disturbances of eating behaviour before and after surgery remain largely unknown.
This study aims to identify the predictive factors of weight loss after pharmacological or surgical treatment, as well as the cognitive and biological mechanisms that mediate this effect.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pr Amandine Everard, Professor
- Phone Number: +32 + 32 (0)2 436 22 10
- Email: amandine.everard@uclouvain.be
Study Contact Backup
- Name: Yannick Deswysen, Doctor
- Phone Number: +32 + 32 2 764 22 13
- Email: yannick.deswysen@saintluc.uclouvain.be
Study Locations
-
-
Brussels Capital
-
Brussels, Brussels Capital, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint-luc
-
Contact:
- Dr Yannick Deswysen, Doctor
- Phone Number: +32 (0) 2 764 22 13
- Email: yannick.deswysen@saintluc.uclouvain.be
-
Principal Investigator:
- Yannick Deswysen, Doctor
-
Sub-Investigator:
- Audrey Loumaye, Professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants initiating an anti-obesity medication or candidates for bariatric surgery once its indication has been validated by a multidisciplinary committee, following medical, nutritional and psychological evaluations.
Description
Inclusion criteria:
- Age between 18 and 65 years
- Obesity, with bariatric surgery indicated after a multidisciplinary evaluation in case of surgical treatment.
- Good physical and mental health, enabling informed consent.
- French speaker
Exclusion criteria:
- Legal protection
- Pregnancy or breastfeeding
- History of bariatric surgery (except gastric banding, provided it was removed more than five years ago).
- Acute or progressive chronic disease
- Alcohol consumption of more than 20 g/day
- Inflammatory bowel disease;
- Digestive autonomic diabetic neuropathy.
- Consumption of dietary supplements (stanols, probiotics, prebiotics or omega-3).
- Following a vegan or gluten-free diet or being lactose intolerant.
- Fibre consumption >30 g/day
- Recent change in antidiabetic medication within the past 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between weight loss after treatment and clinical, neuropsychological and biological parameters.
Time Frame: Throughout the entire study, aproximately during 5 years
|
The percentage of excessive weight loss after treatment will be correlated with
|
Throughout the entire study, aproximately during 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Binge Eating Disorder.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Evaluation of eating disorders using the Binge Eating Scale (BES).
|
Throughout the entire study, aproximately during 5 years
|
|
Food Addiction.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Evaluation of food addiction will be performed using modified Yale Food Addiction Scale 2.0.
|
Throughout the entire study, aproximately during 5 years
|
|
Eating attitudes
Time Frame: Throughout the entire study, aproximately during 5 years
|
Eating patterns and habits will be screened using the Eating Attitude Test 26
|
Throughout the entire study, aproximately during 5 years
|
|
Cognitive flexibility.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Neuropsychological evaluation of cognitive flexibility will be performed with the Trail Making Test
|
Throughout the entire study, aproximately during 5 years
|
|
Impulsivity.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Impulsivity will be assessed using the Barrat Impulsiveness Scale (BIS)
|
Throughout the entire study, aproximately during 5 years
|
|
Self-reported quality of life.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Self-reported quality of life will be assessed using the QOLOD (Quality of Life, Obesity and Dietetics)
|
Throughout the entire study, aproximately during 5 years
|
|
Obesity.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Weight will be measured at each timepoint
|
Throughout the entire study, aproximately during 5 years
|
|
Physical activity.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Weekly physical activity will be reported with the Godin Leisure Time Exercise Questionnaire (GLTEQ)
|
Throughout the entire study, aproximately during 5 years
|
|
Food intake.
Time Frame: Throughout the entire study, aproximately during 5 years
|
Eating habits will be recorded with a Food Frequency Questionnaire (FFQ)
|
Throughout the entire study, aproximately during 5 years
|
|
Blood samples
Time Frame: Throughout the entire study, aproximately during 5 years
|
Blood samples will be collected and processed for metabolomic analyses.
|
Throughout the entire study, aproximately during 5 years
|
|
Fecal sample
Time Frame: Throughout the entire study, aproximately during 5 years
|
Feces samples will be collected and processed to evaluation gut-microbiota composition
|
Throughout the entire study, aproximately during 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic data
Time Frame: Once at inclusion
|
Number of children and marital status will be recorded
|
Once at inclusion
|
|
Medical history
Time Frame: Once at inclusion
|
Information concerning medical comorbidities will be collected from the patient medical record.
|
Once at inclusion
|
|
Childhood Trauma.
Time Frame: Once at inclusion
|
Assessment of adverse life events and trauma will used the Childhood Trauma Questionnaire - short form.
|
Once at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amandine Everard, Professor, Université Catholique de Louvain
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2026
Primary Completion (Estimated)
June 1, 2032
Study Completion (Estimated)
January 1, 2036
Study Registration Dates
First Submitted
January 13, 2026
First Submitted That Met QC Criteria
February 6, 2026
First Posted (Actual)
February 11, 2026
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCAPrediBaria
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Obesity & Overweight
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
National Taiwan University HospitalCompleted
-
PfizerNot yet recruitingObesity | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Overweight or Obesity | Overweight and/or Obesity | Nutritional and Metabolic DiseasesUnited States
-
University of Texas Southwestern Medical CenterChildren's Medical Center DallasRecruitingPediatric Obesity | Pediatric Overweight | Overweight , ObesityUnited States
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
-
University of British ColumbiaTerminatedOverweight and ObesityCanada
Clinical Trials on Pharmacological or surgical treament of obesity
-
Baylor Research InstituteCompleted
-
Hospices Civils de LyonRecruitingSleeve Gastrectomy | Gastric Bypass Surgery | Metabolic Dysfunction-Associated Steatohepatitis | Metabolic Dysfunction-Associated Steatotic Liver DiseaseFrance
-
University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Completed
-
Azienda Ospedaliera Universitaria Integrata VeronaFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione IRCCS... and other collaboratorsUnknown
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed
-
Shanghai East HospitalNot yet recruiting
-
The Methodist Hospital Research InstituteTerminatedHeart Failure | Ventricular DysfunctionUnited States
-
Hopital Antoine BeclereUnknown
-
University Hospital, MontpellierRecruitingCancer T1-N0 or T2-N0 of the Oral CavityFrance
-
Olympus Biotech CorporationCompleted