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NCT Number: NCT06708117

Exploring the Effects of Obesity and Bariatric Surgery on the Brain Using Magnetic Resonance Imaging

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.

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Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

A. 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.

B. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

A. Bariatric Surgery Participants

Inclusion criteria

(Eligibility for Study Participation):

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.

Exclusion criteria

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.

B. Healthy Normal-Weight Participants

Inclusion criteria

(Eligibility for Study Participation):

Aged 20 to 65 years.
BMI between 18.5 and 24.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Po-Jen Yang, MD, PhD

CONTACT

[email protected]

+886-2-23123456 ext. 265005

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2030
First posted: Nov 27, 2024
Registry last updated: Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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