None listed
Conditions
Interventions
None listed
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Obese Patient Group (Study Group): Patients with severe obesity who have decided to undergo bariatric surgery (BMI = 30 kg/m² with metabolic comorbidities, or BMI = 35 kg/m²). Metabolic comorbidities include at least one of the following: impaired fasting glucose, HbA1c = 5.7%, diabetes, fatty liver disease, hypertension, hypertriglyceridemia, or metabolic syndrome. ? Normal Weight Group (Control Group): Patients with normal weight based on the Asian obesity criteria (18.5 kg/m² = BMI < 23 kg/m²) who have decided to undergo gastrectomy for early gastric cancer (cT1). ? Eligibility Criteria for Both Study and Control Groups: Age: 19 to 75 years old. Individuals who have received a detailed explanation of the clinical trial, fully understand its purpose and procedures, voluntarily agree to participate as research subjects, and provide written informed consent to comply with the study requirements.
Exclusion criteria
Exclusion criteria: ? Study Group: Patients scheduled for bariatric surgery, excluding those scheduled for gastric banding surgery or undergoing revisional surgery. ? Control Group: Individuals in the control group with a history of weight loss or prior gastrointestinal surgery are excluded. ? Exclusion Criteria for Both Study and Control Groups: Individuals who have consumed an average daily alcohol amount exceeding 30g for men (approximately 3 shots of soju) or 20g for women (approximately 2 shots of soju) for more than 3 months within the past 5 years (equivalent to over 3 bottles of soju per week for men and 2 bottles for women). Individuals with a history of using medications that can induce secondary fatty liver within the past year (e.g., corticosteroids, tamoxifen, amiodarone, methotrexate, HAART). Individuals with confirmed liver diseases, including hepatitis B or C, autoimmune hepatitis, drug-induced liver injury, or other liver diseases (e.g., alpha-1 antitrypsin deficiency, primary biliary cirrhosis, primary sclerosing cholangitis), as well as biliary diseases. Pregnant women. Individuals deemed unsuitable for participation in the clinical trial by the principal investigator or responsible physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of specific biomarker candidates associated with innate immunity-mediated chronic inflammation through transcriptomic analysis of stomach, liver, and adipose tissues obtained from the study group and control group during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Verification of Biomarker Relevance Through Comparative Analysis of Pre- and Post-Operative Cytokine and Metabolite Changes in Blood and Urine of Experimental and Control Groups;Correlation Between Fat Fraction (%) in MRI-PDFF and Histological Severity of Hepatic Steatosis, and Evaluation of NAFLD Improvement Before and After Surgery;Evaluation of Liver Fibrosis Improvement Before and After Surgery Through the Correlation Between Histological Fibrosis Degree and Liver Stiffness Measurement (LSM, kPa) in MRE;Relationship Between Changes in Pancreas Fat in MRI-PDFF Before and After Surgery and Diabetes Improvement;Analysis of Changes in Abdominal Fat (Visceral and Subcutaneous) and Muscle Mass (Sarcopenia Status) at the L3-4 Level in MRI Before and After Surgery;Analysis of Pre- and Post-Operative DEXA Results to Assess Changes in Body Composition | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hyeon Park
Gachon University Gil Medical Center
Outcome results
None listed