Obesity &Amp; OverweightNCT07126743
Organic Pollutant Build-Up in Body Fat and Stomach Tissue Linked to Obesity Levels
An observational study of Obesity &Amp; Overweight, run by Dong Peng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- exposure to organic pollutant
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Accumulation Profiles of Specific Organic Pollutants in Adipose and Gastric Tissues of Bariatric Surgery Patients and Their Clinical Correlations With Obesity Severity
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.
Read the detailed description
Obesity is a complex health condition influenced by both lifestyle and environmental factors. Among these factors, persistent organic pollutants (POPs) - such as certain plastic-related chemicals, pesticides, and industrial byproducts - have raised growing concern due to their ability to accumulate in human tissues over time and potentially interfere with metabolism.
This study focuses on patients with obesity who are undergoing bariatric surgery. During surgery, the investigators will collect small samples of adipose (fat) tissue and gastric tissue under sterile conditions. These samples will be analyzed for the presence and concentration of specific organic pollutants using validated laboratory methods. The investigators will compare pollutant accumulation patterns across patients with varying levels of obesity severity, aiming to identify possible associations between pollutant burden and obesity-related clinical characteristics.
The results are expected to provide new insights into the environmental contributions to obesity, beyond diet and physical activity. By clarifying how pollutant accumulation in different tissues relates to obesity severity, the findings could help inform prevention strategies, refine clinical management, and highlight the need for targeted public health policies addressing environmental exposures.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- exposure to organic pollutant
- Keywords
- Metabolic syndrome, Organic pollutants, Obesity
- Medical subject headings
- Obesity, Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to organic pollutantOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: exposure to organic pollutant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline (within 1 month before bariatric surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126743
- Sponsor's protocol ID
- 2025-527-01
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) will not be shared due to concerns regarding patient privacy, the sensitive nature of surgical and tissue analysis data, and applicable institutional and regulatory restrictions. Summary-level results will be made available in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accumulation Profiles of Specific Organic Pollutants in Adipose and Gastric Tissues of Bariatric Surgery Patients and Their Clinical Correlations With Obesity Severity
- ClinicalTrials.gov ID
- NCT07126743
- Acronym / sponsor ID
- 2025-527-01
- Conditions
- Obesity &Amp; Overweight
- Keywords
- Metabolic syndrome, Organic pollutants, Obesity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a complex health condition influenced by both lifestyle and environmental factors. Among these factors, persistent organic pollutants (POPs) - such as certain plastic-related chemicals, pesticides, and industrial byproducts - have raised growing concern due to their ability to accumulate in human tissues over time and potentially interfere with metabolism.
This study focuses on patients with obesity who are undergoing bariatric surgery. During surgery, the investigators will collect small samples of adipose (fat) tissue and gastric tissue under sterile conditions. These samples will be analyzed for the presence and concentration of specific organic pollutants using validated laboratory methods. The investigators will compare pollutant accumulation patterns across patients with varying levels of obesity severity, aiming to identify possible associations between pollutant burden and obesity-related clinical characteristics.
The results are expected to provide new insights into the environmental contributions to obesity, beyond diet and physical activity. By clarifying how pollutant accumulation in different tissues relates to obesity severity, the findings could help inform prevention strategies, refine clinical management, and highlight the need for targeted public health policies addressing environmental exposures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obesity group | – | Other: exposure to organic pollutantAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to organic pollutantSmall 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). | Other | obesity group |
Primary outcome
Obesity Severity
Time frame: At baseline (within 1 month before bariatric surgery).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No. individual participant data (IPD) will not be shared due to concerns regarding patient privacy, the sensitive nature of surgical and tissue analysis data, and applicable institutional and regulatory restrictions. Summary-level results will be made available in publications and presentations.
Related trials for Obesity &Amp; Overweight
RecruitingPhase 2
UBT251 Injection Phase II Clinical Study (CKD)
Obesity &Amp; Overweight, Chronic Kidney Disease
Active, not recruiting
E-Bike Commuting and Health in Overweight College Students
Obesity &Amp; Overweight, Sedentary Behaviors
Not yet recruiting
EAT SMART Teen Study
Obesity &Amp; Overweight
Active, not recruiting
Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity
Obesity &Amp;Amp;Amp; Overweight, Environmental Exposure
Active, not recruiting
Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders
Obesity &Amp; Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity &Amp; Overweight, run by Dong Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity Severity (time frame: At baseline (within 1 month before bariatric surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.