Effects of Bariatric Surgery and Liraglutide on Weight Loss and Brain Function in Obesity
Effects of Bariatric Surgery and Pharmacological Therapy with Liraglutide on Motivational and Inhibitory Processes: Cognitive-Behavioral Markers of Long-Term Weight Loss. a Study on Patients with Obesity.
This study tests how bariatric surgery and the medication liraglutide affect weight loss and brain function in people with obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT06720246 on ClinicalTrials.gov |
What this trial studies
This research project investigates how bariatric surgery and liraglutide treatment influence cognitive-behavioral processes related to weight loss in obese patients. It focuses on two brain networks: the cue-reactivity network, which responds to food stimuli, and the cue-regulation network, which governs decision-making and inhibitory control. The study aims to identify cognitive-behavioral markers that predict treatment responses and how these processes are affected by feelings of satiety. Participants will be individuals already selected for surgery or liraglutide treatment, and their brain activity will be monitored to assess changes over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 60 with a BMI of 30 kg/m² or higher, scheduled for bariatric surgery or liraglutide treatment.
Not a fit: Patients with significant neurological or psychiatric disorders, or those with a BMI below 30 kg/m², may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the cognitive-behavioral factors that contribute to long-term weight loss, leading to improved treatment strategies for obesity.
How similar studies have performed: While studies have explored the effects of bariatric surgery and GLP-1 agonists on weight loss, this specific focus on cognitive-behavioral markers and brain network activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects of any ethnicity, aged between 20 and 60 years. * BMI equal to or greater than 30 kg/m². * No history of neurological or psychiatric disorders, as confirmed through medical history and neuropsychological screening. * Signed informed consent and willingness to comply with all study procedures. * Patients scheduled for surgery, treatment with liraglutide, or a dietary regimen. Exclusion Criteria: * Previous diagnosis of significant neurological conditions (e.g., brain injury or dementia) or major psychiatric disorders. * Current or past psychopharmacological therapy, if prolonged. * BMI lower than 30 kg/m². * Lack of signed informed consent. * Severe medical conditions, including but not limited to: hypertension, significant cardiac disease, or other disorders that may compromise patient safety. * Confirmed pregnancy through self-report and/or breastfeeding.
Where this trial is running
Milan, Milan
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Eraldo Paulesu, MD
- Email: eraldo.paulesu@unimib.it
- Phone: +390264483748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.