Impact of Bariatric Surgery and Liraglutide on Cognitive-Behavioral Markers of Long-Term Weight Loss in Obesity

NCT06720246 | Recruiting

• 2 other identifiers: BALANCERC2024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The present research project aims to study the effects of bariatric surgery and liraglutide administration (in patients already selected for one of these procedures) on two cognitive-behavioral processes partially supported by distinct brain networks: automatic approach tendencies (underpinned by the cue-reactivity network) and behavioral inhibition (underpinned by the cue-regulation network). Additionally, the investigators aim to study how these processes may be modulated by satiety. The secondary objective of the project includes identifying cognitive-behavioral markers that can predict the response to these treatments.

Conditions

Obesity and Overweight

Keywords

Obesity; Bariatric surgery; food cognition; liraglutide

Outcome Measures

Primary Outcomes (2)

• Reaction times (approach bias)

  Changes in reaction times (approach bias) in response to pictures of high-calorie and low-calorie foods after treatment.

  Baseline and after treatment (2-4 months)

• Accuracy (inhibition)

  Changes in accuracy (inhibition) in response to high-calorie and low-calorie food pictures after treatment.

  Baseline and after treatment (2-4 months)

Study Arms (2)

Bariatric Surgery

Patients submitted to bariatric surgery

Liraglutide

Patients submitted to liraglutide treatment

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited at the IRCCS Galeazzi-Sant'Ambrogio, Milan.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milan, 20100, Italy

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eraldo Paulesu, MD

CONTACT

+390264483748; eraldo.paulesu@unimib.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)