NCT06826586

Brief 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 microplastics on the visceral microbiota and metabolic profiles of obese patients by combining the macro-genomic and metabolomics approaches.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Keywords

microplasticsobesitymacro-genomicmetabolomics

Outcome Measures

Primary Outcomes (1)

  • Differences in microbial communities

    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.

Study Arms (1)

obesity group

BMI≧30

Diagnostic Test: Measuring the microplastics

Interventions

Measuring the type, nature, and abundance of microplastics in stomach, liver, feces, and blood

obesity group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with obesity

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Individual participant data was not allowed sharing in our ethics committee.

Locations