- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06826586
Identification of Microplastics in Liver, Stomach, Blood, and Feces of Obese Patients and Their Association Analysis with Macrogenomics and Metabolomics.
February 10, 2025 updated by: Dong Peng, First Affiliated Hospital of Chongqing Medical University
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients diagnosed with obesity
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
obesity group
BMI≧30
|
Measuring the type, nature, and abundance of microplastics in stomach, liver, feces, and blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From the diagnosis of obesity, through study completion, an average of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 10, 2025
First Submitted That Met QC Criteria
February 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-099-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data was not allowed sharing in our ethics committee.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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