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

NCT06708117 | Not Yet Recruiting

• 1 other identifier: 202406090RINA
• Study Type: observational
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Obesity; Bariatric Surgery Candidate

Keywords

obesity; bariatric surgery; brain; magnetic resonance imaging

Outcome Measures

Primary Outcomes (4)

• Bariatric surgery-related structural changes as assessed by gray matter volume

  Acquiring structural brain MR images before and six months after bariatric surgery

  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

  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

  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

  From enrollment to brain MRI

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A. Bariatric Surgery Participants B. Healthy Normal-Weight Participants

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Po-Jen Yang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Jen Yang, MD, PhD

CONTACT

+886-2-23123456; paulpjyang@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 29, 2024

Record last verified: 2024-11