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Clinical Trials/NCT06708117
NCT06708117Not yet recruitingNot Applicable

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

National Taiwan University Hospital0 sites260 target enrollmentStarted: January 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
260
Primary Endpoint
Bariatric surgery-related structural changes as assessed by gray matter volume

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

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
  • 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.

Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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