ObesityNCT06708117
Exploring the Effects of Obesity and Bariatric Surgery on the Brain Using Magnetic Resonance Imaging
An observational study of Obesity and Bariatric Surgery Candidate, run by National Taiwan University Hospital.
Trial summary
Background and Purpose: The causes of obesity are highly complex, with eating behaviors playing a crucial role. Current research indicates that many brain regions are involved in the regulation of appetite, eating behaviors, and obesity, but the detailed mechanisms remain unclear. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2030
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A. Bariatric Surgery Participants B. Healthy Normal-Weight Participants
Who may be able to join
- Aged 20 years or older.
- Body mass index (BMI) ≥ 37.5, or BMI ≥ 27 with obesity-related comorbidities such as type 2 diabetes, hypertension, or obstructive sleep apnea.
- Scheduled to undergo bariatric surgery for obesity treatment.
- Aged 20 to 65 years.
- BMI between 18.5 and 24.
Who cannot join
- Presence of neurological or psychiatric disorders.
- Use of neurological or psychiatric medications.
- Diagnosis of cancer or major gastrointestinal diseases.
- History of major abdominal surgery.
- Presence of metallic implants in the body.
- Claustrophobia.
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- Currently pregnant.
- Healthy Normal-Weight Participants
- Presence of neurological or psychiatric disorders.
- Use of neurological or psychiatric medications.
- Diagnosis of cancer or major gastrointestinal diseases.
- History of major abdominal surgery.
- Presence of metallic implants in the body.
- Claustrophobia.
- Currently pregnant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background and Purpose:
The causes of obesity are highly complex, with eating behaviors playing a crucial role. Current research indicates that many brain regions are involved in the regulation of appetite, eating behaviors, and obesity, but the detailed mechanisms remain unclear. Bariatric surgery has been shown to effectively achieve long-term weight loss and improve obesity-related conditions in severely obese patients, making it a valuable research platform for obesity treatment. Recent studies have found that after bariatric surgery, patients experience reduced hunger, increased satiety, and altered responses and preferences for food stimuli. Magnetic resonance imaging (MRI) is a widely used tool for analyzing brain structure and functional changes. Recent imaging studies have demonstrated changes in brain structure and connectivity across multiple regions after bariatric surgery. However, due to the complexity of brain structure and these changes, many questions remain unanswered. This study aims to investigate the effects of obesity and bariatric surgery on brain structure and function using MRI, to identify potential mechanisms for treating obesity.
Read more
Methods:
This study plans to recruit 200 obese patients aged 20 years or older who are scheduled to undergo bariatric surgery within a 5-year period. Participants will undergo brain MRI scans before and six months after surgery. At these two time points, they will also complete the Dutch Eating Behavior Questionnaire (DEBQ) to assess changes in eating behaviors and provide blood samples for the analysis of gastrointestinal, obesity-related, and appetite-related hormones. Additionally, 60 healthy individuals with normal weight will be recruited as a control group to undergo the same brain MRI scans, DEBQ assessments, and blood analyses. This control group will help explore the effects of obesity and bariatric surgery on brain structure and function.
Expected Results:
This study is expected to reveal the structural and functional changes in brain MRI associated with obesity and bariatric surgery, providing insights into potential mechanisms for treating obesity.
Read the detailed description
- Bariatric Surgery Participants Obese patients scheduled for bariatric surgery will be recruited through the Bariatric Surgery Outpatient Clinic of the Department of Surgery at National Taiwan University Hospital (NTUH). Physicians and research staff will explain the study procedures to the patients.
- Healthy Normal-Weight Participants Healthy participants will be recruited via promotional materials distributed within NTUH and online. Physicians and research staff will explain the study procedures to the participants.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- obesity, bariatric surgery, brain, magnetic resonance imaging
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Bariatric surgery-related structural changes as assessed by gray matter volume
Acquiring structural brain MR images before and six months after bariatric surgery
Measured: Baseline and 6 months after bariatric surgery
Bariatric surgery-related changes in functional connection between brain areas as assessed by Pearson's correlation coefficient
Performing resting-state functional MRI before and six months after bariatric surgery
Measured: Baseline and 6 months after bariatric surgery
Obesity-related structural changes as assessed by gray matter volume
Acquiring structural brain MR images in health controls and bariatric patents before surgery
Measured: From enrollment to brain MRI
Obesity-related changes in functional connection between brain areas as assessed by Pearson's correlation coefficient
Performing resting-state functional MRI in health controls and bariatric patents before surgery
Measured: From enrollment to brain MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 260 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Jen Yang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708117
- Sponsor's protocol ID
- 202406090RINA
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Obesity and Bariatric Surgery on the Brain Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06708117
- Acronym / sponsor ID
- 202406090RINA
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- obesity, bariatric surgery, brain, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Nov 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.
Background and Purpose:
The causes of obesity are highly complex, with eating behaviors playing a crucial role. Current research indicates that many brain regions are involved in the regulation of appetite, eating behaviors, and obesity, but the detailed mechanisms remain unclear. Bariatric surgery has been shown to effectively achieve long-term weight loss and improve obesity-related conditions in severely obese patients, making it a valuable research platform for obesity treatment. Recent studies have found that after bariatric surgery, patients experience reduced hunger, increased satiety, and altered responses and preferences for food stimuli. Magnetic resonance imaging (MRI) is a widely used tool for analyzing brain structure and functional changes. Recent imaging studies have demonstrated changes in brain structure and connectivity across multiple regions after bariatric surgery. However, due to the complexity of brain structure and these changes, many questions remain unanswered. This study aims to investigate the effects of obesity and bariatric surgery on brain structure and function using MRI, to identify potential mechanisms for treating obesity.
Methods:
This study plans to recruit 200 obese patients aged 20 years or older who are scheduled to undergo bariatric surgery within a 5-year period. Participants will undergo brain MRI scans before and six months after surgery. At these two time points, they will also complete the Dutch Eating Behavior Questionnaire (DEBQ) to assess changes in eating behaviors and provide blood samples for the analysis of gastrointestinal, obesity-related, and appetite-related hormones. Additionally, 60 healthy individuals with normal weight will be recruited as a control group to undergo the same brain MRI scans, DEBQ assessments, and blood analyses. This control group will help explore the effects of obesity and bariatric surgery on brain structure and function.
Expected Results:
This study is expected to reveal the structural and functional changes in brain MRI associated with obesity and bariatric surgery, providing insights into potential mechanisms for treating obesity.
Detailed description
- Bariatric Surgery Participants Obese patients scheduled for bariatric surgery will be recruited through the Bariatric Surgery Outpatient Clinic of the Department of Surgery at National Taiwan University Hospital (NTUH). Physicians and research staff will explain the study procedures to the patients.
- Healthy Normal-Weight Participants Healthy participants will be recruited via promotional materials distributed within NTUH and online. Physicians and research staff will explain the study procedures to the participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A. Bariatric Surgery Participants B. Healthy Normal-Weight Participants
Key inclusion criteria (5 listed)
- Aged 20 years or older.
- Body mass index (BMI) ≥ 37.5, or BMI ≥ 27 with obesity-related comorbidities such as type 2 diabetes, hypertension, or obstructive sleep apnea.
- Scheduled to undergo bariatric surgery for obesity treatment.
- Aged 20 to 65 years.
- BMI between 18.5 and 24.
Key exclusion criteria (15 listed)
- Presence of neurological or psychiatric disorders.
- Use of neurological or psychiatric medications.
- Diagnosis of cancer or major gastrointestinal diseases.
- History of major abdominal surgery.
- Presence of metallic implants in the body.
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
Bariatric surgery-related structural changes as assessed by gray matter volume
Time frame: Baseline and 6 months after bariatric surgery
Acquiring structural brain MR images before and six months after bariatric surgery
Bariatric surgery-related changes in functional connection between brain areas as assessed by Pearson's correlation coefficient
Time frame: Baseline and 6 months after bariatric surgery
Performing resting-state functional MRI before and six months after bariatric surgery
Obesity-related structural changes as assessed by gray matter volume
Time frame: From enrollment to brain MRI
Acquiring structural brain MR images in health controls and bariatric patents before surgery
Obesity-related changes in functional connection between brain areas as assessed by Pearson's correlation coefficient
Time frame: From enrollment to brain MRI
Performing resting-state functional MRI in health controls and bariatric patents before surgery
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 29 Nov 2024.
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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.
Po-Jen Yang, MD, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by National Taiwan University Hospital.
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 15 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Po-Jen Yang, MD, PhD (+886-2-23123456 ext. 265005, paulpjyang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bariatric surgery-related structural changes as assessed by gray matter volume (time frame: Baseline and 6 months after bariatric surgery). The study lists 4 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 29 Nov 2024.