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Recruiting NCT07402031

Predicting Weight Loss After Pharmacological or Surgical Treatment in Patients With Obesity

— Observational Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacological or surgical treament of obesity.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Research of Predictive Factors of Weight Loss After Pharmacological or Surgical Treatment in Patients Suffering From Obesity

Overview

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.

Interventions

  • Procedure Pharmacological or surgical treament of obesity
    Longitudinal follow-up of participants who initiate an anti-obesity medication or whose application for bariatric surgery was accepted. It will combine anthropometric, clinical, neuropsychological and biological measurements taken at various timepoints. Participants will be asked to complete a set of online questionnaires and data will be recorded anonymously. Biological samples will be collected at various time points.

Primary outcome measures

  • Correlation between weight loss after treatment and clinical, neuropsychological and biological parameters. [Time frame: Throughout the entire study, aproximately during 5 years]
Secondary outcome measures (11)
  • Binge Eating Disorder. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Food Addiction. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Eating attitudes [Time frame: Throughout the entire study, aproximately during 5 years]
  • Cognitive flexibility. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Impulsivity. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Self-reported quality of life. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Obesity. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Physical activity. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Food intake. [Time frame: Throughout the entire study, aproximately during 5 years]
  • Blood samples [Time frame: Throughout the entire study, aproximately during 5 years]
  • Fecal sample [Time frame: Throughout the entire study, aproximately during 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Cliniques Universitaires Saint-Luc — Brussels

Identifiers

NCT: NCT07402031 · TCAPrediBaria

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗