Obesity and OverweightBalanceNCT06720246
Impact of Bariatric Surgery and Liraglutide on Cognitive-Behavioral Markers of Long-Term Weight Loss in Obesity
An observational study of Obesity and Overweight, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity and Overweight
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jun 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be recruited at the IRCCS Galeazzi-Sant'Ambrogio, Milan.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milan, 20100
About this study
Official title: 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.
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.
Read the detailed description
Experimental and meta-analytic neuroimaging studies have highlighted two primary brain networks whose functioning or structure is altered in patients with obesity: (i) the "cue-reactivity network," involved in sensory, hedonic, and motivational responses to food, and (ii) the "cue-regulation network," more prominently involved in attentional, decision-making, and inhibitory processes. In line with this theoretical framework, weight loss induced by pharmacological treatments or bariatric surgery is associated with a partial recovery of the functioning and structure of these brain networks.
Following a sleeve gastrectomy, obese patients exhibit reduced activity in the reward circuit and increased activity in the inhibitory control circuit in response to high-calorie food images, suggesting a normalization of brain responses to food after bariatric surgery. Moreover, these changes in brain functionality may be accompanied by increased gray matter density in the prefrontal cortex, which persists for up to 12 months following sleeve gastrectomy or Roux-en-Y gastric bypass.
Pharmacologically, the administration of glucagon-like peptide-1 receptor (GLP-1) agonists-such as liraglutide, semaglutide, and exenatide-has proven effective in treating diabetes and promoting weight loss. fMRI studies have shown that intravenous administration of exenatide (vs. placebo) in patients with obesity and type 2 diabetes reduces neurofunctional activity in key nodes of the cue-reactivity network (e.g., amygdala, putamen, insula) in response to high-calorie food images. Furthermore, this effect is nullified if exenatide administration is preceded by GLP-1 receptor blockade.
However, it remains unclear whether such surgical or pharmacological treatments are accompanied by changes in cognitive processes associated with reactivity to edible stimuli or behavioral inhibition, and whether these contribute to an improved post-operative response to satiety.
This research project thus 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 involves identifying cognitive-behavioral markers that could predict responses to these treatments.
- Conditions
- Obesity and Overweight
- Keywords
- Obesity, Bariatric surgery, food cognition, liraglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Patients submitted to bariatric surgery | |
| Liraglutide | Patients submitted to liraglutide treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction times (approach bias)
Changes in reaction times (approach bias) in response to pictures of high-calorie and low-calorie foods after treatment.
Measured: 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.
Measured: Baseline and after treatment (2-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start26 Jun 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720246
- Sponsor's protocol ID
- BALANCE
- Other IDs
- RC2024
- Acronym
- Balance
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06720246
- Acronym / sponsor ID
- Balance / BALANCE
- Conditions
- Obesity and Overweight
- Keywords
- Obesity, Bariatric surgery, food cognition, liraglutide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Experimental and meta-analytic neuroimaging studies have highlighted two primary brain networks whose functioning or structure is altered in patients with obesity: (i) the "cue-reactivity network," involved in sensory, hedonic, and motivational responses to food, and (ii) the "cue-regulation network," more prominently involved in attentional, decision-making, and inhibitory processes. In line with this theoretical framework, weight loss induced by pharmacological treatments or bariatric surgery is associated with a partial recovery of the functioning and structure of these brain networks.
Following a sleeve gastrectomy, obese patients exhibit reduced activity in the reward circuit and increased activity in the inhibitory control circuit in response to high-calorie food images, suggesting a normalization of brain responses to food after bariatric surgery. Moreover, these changes in brain functionality may be accompanied by increased gray matter density in the prefrontal cortex, which persists for up to 12 months following sleeve gastrectomy or Roux-en-Y gastric bypass.
Pharmacologically, the administration of glucagon-like peptide-1 receptor (GLP-1) agonists-such as liraglutide, semaglutide, and exenatide-has proven effective in treating diabetes and promoting weight loss. fMRI studies have shown that intravenous administration of exenatide (vs. placebo) in patients with obesity and type 2 diabetes reduces neurofunctional activity in key nodes of the cue-reactivity network (e.g., amygdala, putamen, insula) in response to high-calorie food images. Furthermore, this effect is nullified if exenatide administration is preceded by GLP-1 receptor blockade.
However, it remains unclear whether such surgical or pharmacological treatments are accompanied by changes in cognitive processes associated with reactivity to edible stimuli or behavioral inhibition, and whether these contribute to an improved post-operative response to satiety.
This research project thus 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 involves identifying cognitive-behavioral markers that could predict responses to these treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | – | –Patients submitted to bariatric surgery |
| Liraglutide | – | –Patients submitted to liraglutide treatment |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited at the IRCCS Galeazzi-Sant'Ambrogio, Milan.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reaction times (approach bias)
Time frame: Baseline and after treatment (2-4 months)
Changes in reaction times (approach bias) in response to pictures of high-calorie and low-calorie foods after treatment.
Accuracy (inhibition)
Time frame: Baseline and after treatment (2-4 months)
Changes in accuracy (inhibition) in response to high-calorie and low-calorie food pictures after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eraldo Paulesu, MD (+390264483748, eraldo.paulesu@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction times (approach bias) (time frame: Baseline and after treatment (2-4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.