Organic Pollutant Build-Up in Body Fat and Stomach Tissue Linked to Obesity Levels

NCT07126743 | Active Not Recruiting DMC

• 1 other identifier: 2025-527-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at whether certain environmental chemicals, called organic pollutants, build up in the body fat and stomach tissues of people with obesity who are having weight-loss (bariatric) surgery. These pollutants can come from things like plastics, pesticides, or industrial waste, and may affect health in different ways. The investigators will measure the amount of these pollutants in tissue samples taken during surgery and see if the levels are different in people with mild, moderate, or severe obesity. By understanding these patterns, the investigators hope to learn more about how environmental factors may influence obesity and related health problems. The findings could help guide future prevention and treatment strategies for patients.

Conditions

Obesity &Amp; Overweight

Keywords

Metabolic syndrome; Organic pollutants; Obesity

Outcome Measures

Primary Outcomes (1)

• Obesity Severity

  The investigators will assess obesity severity based on body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²). BMI will be obtained using standardized measurements of height and weight during the preoperative evaluation. Obesity severity will be categorized according to World Health Organization (WHO) criteria (Class I: 30.0-34.9 kg/m², Class II: 35.0-39.9 kg/m², Class III: ≥ 40.0 kg/m²).

  At baseline (within 1 month before bariatric surgery).

Study Arms (1)

obesity group

Adult patients diagnosed with obesity (body mass index ≥ 30 kg/m²) who are scheduled to undergo bariatric surgery for clinical indications, such as severe obesity or obesity-related comorbidities (e.g., type 2 diabetes, hypertension, dyslipidemia, or obstructive sleep apnea). The intervention of interest is the standardized collection of biological tissue samples during bariatric surgery. At the time of surgery, the investigators will obtain small samples of subcutaneous and visceral adipose tissue, as well as gastric tissue from the resected portion of the stomach, using sterile techniques. No additional incisions or surgical time beyond the standard bariatric procedure will be required.

Other: exposure to organic pollutant

Interventions

exposure to organic pollutant OTHER

Small samples of subcutaneous and visceral adipose tissue will be analyzed for the presence and concentration of specific organic pollutants using validated analytical chemistry methods, such as gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS).

obesity group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients with obesity (BMI ≥30 kg/m²) scheduled to undergo primary bariatric surgery, including sleeve gastrectomy or Roux-en-Y gastric bypass, at participating surgical centers. Participants will represent a range of obesity severities (Class I-III) and may have obesity-related comorbidities such as type 2 diabetes, hypertension, dyslipidemia, or obstructive sleep apnea. All participants must be able to provide informed consent and agree to intraoperative collection of adipose and gastric tissue samples for organic pollutant analysis.

You may qualify if:

• Adults ≥18 years.
• BMI ≥30 kg/m² at screening (measured within 30 days before surgery).
• Scheduled for primary bariatric surgery (e.g., sleeve gastrectomy or Roux-en-Y gastric bypass) for clinical indications.
• Able to provide informed consent.
• Willing to allow intraoperative collection of subcutaneous/visceral adipose tissue and gastric tissue for pollutant analysis.
• Availability of basic preoperative clinical data (demographics, comorbidities, relevant labs).

You may not qualify if:

• Prior bariatric or major upper gastrointestinal surgery that alters stomach/anatomy relevant to sampling.
• Pregnant or breastfeeding at screening or on day of surgery.
• Active malignancy (excluding non-melanoma skin cancers) or ongoing systemic immunosuppressive therapy (e.g., chronic corticosteroids, biologics) within 3 months.
• Severe organ dysfunction: decompensated cirrhosis (Child-Pugh C) or eGFR \<30 mL/min/1.73m².
• Acute infection or decompensated chronic illness that would preclude elective surgery per treating team.
• Documented high-level occupational or accidental chemical exposure within 6 months (e.g., pesticide poisoning) likely to bias tissue pollutant measurements.
• Participation in another interventional study expected to affect weight or metabolism within 3 months.
• Inadequate tissue obtainable at surgery for analysis (determined intraoperatively by the investigators).

Sponsors & Collaborators

• Dong Peng: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)