Obesity and OverweightNCT06826586
Identification of Microplastics in Liver, Stomach, Blood, and Feces of Obese Patients and Their Association Analysis with Macrogenomics and Metabolomics.
An observational study of Obesity and Overweight, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The aim of this study was to identify and quantify microplastics in the stomach, liver, feces, and blood of obese patients to be treated with bariatric surgery by using a variety of advanced analytical techniques to explore the association between obesity and visceral microplastics, and to investigate the effects of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Measuring the microplastics
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 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: patients diagnosed with obesity
Who may be able to join
- Age ≥18 years old;
- BMI ≧30;
- proposed to undergo bariatric surgery and need to remove part of the liver tissue for fatty liver test;
- complete clinical data and basic information;
- willing to participate in the study and sign the informed consent form.
Who cannot join
- Receive chemotherapy, radiotherapy, immunotherapy;
- have other history of digestive diseases;
- combined with malignant tumors;
- have serious cardiorespiratory insufficiency and other systemic diseases that affect the choice of treatment plan;
- not willing to participate in this study.
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
The aim of this study was to identify and quantify microplastics in the stomach, liver, feces, and blood of obese patients to be treated with bariatric surgery by using a variety of advanced analytical techniques to explore the association between obesity and visceral microplastics, and to investigate the effects of microplastics on the visceral microbiota and metabolic profiles of obese patients by combining the macro-genomic and metabolomics approaches.
- Conditions
- Obesity and Overweight
- Being tested
- Measuring the microplastics
- Keywords
- microplastics, obesity, macro-genomic, metabolomics
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring the microplasticsDiagnostic test
Measuring the type, nature, and abundance of microplastics in stomach, liver, feces, and blood
| Study group | Role | What they receive |
|---|---|---|
| obesity group | BMI≧30 Receives: Diagnostic Test: Measuring the microplastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in microbial communities
Differences in different microbial communities in the stomach, liver, feces, and blood of obese patients
Measured: From the diagnosis of obesity, through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826586
- Sponsor's protocol ID
- 2025-099-01
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data was not allowed sharing in our ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Microplastics in Liver, Stomach, Blood, and Feces of Obese Patients and Their Association Analysis with Macrogenomics and Metabolomics.
- ClinicalTrials.gov ID
- NCT06826586
- Acronym / sponsor ID
- 2025-099-01
- Conditions
- Obesity and Overweight
- Keywords
- microplastics, obesity, macro-genomic, metabolomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 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.
The aim of this study was to identify and quantify microplastics in the stomach, liver, feces, and blood of obese patients to be treated with bariatric surgery by using a variety of advanced analytical techniques to explore the association between obesity and visceral microplastics, and to investigate the effects of microplastics on the visceral microbiota and metabolic profiles of obese patients by combining the macro-genomic and metabolomics approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obesity group | – | Diagnostic Test: Measuring the microplasticsBMI≧30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with obesity
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- BMI ≧30;
- proposed to undergo bariatric surgery and need to remove part of the liver tissue for fatty liver test;
- complete clinical data and basic information;
- willing to participate in the study and sign the informed consent form.
Key exclusion criteria (5 listed)
- Receive chemotherapy, radiotherapy, immunotherapy;
- have other history of digestive diseases;
- combined with malignant tumors;
- have serious cardiorespiratory insufficiency and other systemic diseases that affect the choice of treatment plan;
- not willing to participate in this study.
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 |
|---|---|---|
| Measuring the microplasticsMeasuring the type, nature, and abundance of microplastics in stomach, liver, feces, and blood | Diagnostic test | obesity group |
Primary outcome
Differences in microbial communities
Time frame: From the diagnosis of obesity, through study completion, an average of 1 year.
Differences in different microbial communities in the stomach, liver, feces, and blood of obese patients
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 14 Feb 2025.
- Individual participant dataSharing planned: No. Individual participant data was not allowed sharing in our ethics committee.
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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 and Overweight, run by First Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 5 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 14 Feb 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?
Differences in microbial communities (time frame: From the diagnosis of obesity, through study completion, an average of 1 year.). 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 14 Feb 2025.