Predicting Weight Loss After Pharmacological or Surgical Treatment in Patients With Obesity
Research of Predictive Factors of Weight Loss After Pharmacological or Surgical Treatment in Patients Suffering From Obesity
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Amandine Everard, Professor, Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- TCAPrediBaria
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
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