Environment, Inflammation and Metabolic Diseases Study

April 1, 2026 updated by: Qifu Li
The aim is to establish an effective and practical early warning model for endocrine and metabolic diseases based on an environmental-gene-protein panoramic network, to uncover new mechanisms underlying the onset and progression of these diseases, and to screen for novel therapeutic targets.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to establish a specialized resource database for metabolic diseases-the Chongqing Environment, Inflammation, and Metabolic Diseases Study (EIMDS). The cohort will include approximately 8,000 community-based individuals who have been followed up for over 5 years, with clinical, biochemical, and endpoint event assessments conducted every two years, along with the collection of blood and urine samples. Based on the EIMDS cohort,this study will explore the risk factors for endocrine and metabolic diseases from a population perspective. Furthermore, by employing technologies such as whole-transcriptome sequencing, proteomics and phosphoproteomics, ATAC-seq, and single-cell sequencing,this study aim to elucidate the molecular mechanisms underlying endocrine and metabolic diseases and identify potential drug targets.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Qifu Li, MD, PhD, Chief Physician
  • Phone Number: 023-89011554 +8618696676815
  • Email: liqifu@yeah.net

Study Contact Backup

  • Name: Shumin Yang, MD, PhD, Chief Physician
  • Phone Number: 023-89011554 ‭+8615523552235‬
  • Email: 443068494@qq.com

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study aims to establish a specialized resource database-the Chongqing Environment, Inflammation, and Metabolic Diseases Study (EIMDS). The cohort will include approximately 8,000 community-based individuals who have been followed up for over 10 years. Clinical, biochemical, and endpoint event assessments will be conducted every two years, along with the collection of blood and urine specimens

Description

Inclusion Criteria:

  • All individuals who voluntarily participated in the physical examination

Exclusion Criteria:

Participants with incomplete data

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
hypertension group
Participants with hypertension
Other: observe
A single observational cohort of study participants undergoing baseline biochemical screening for autonomous aldosterone secretion (AAS). No experimental interventions or treatments are administered. All participants receive standard clinical care and undergo standardized baseline assessments, including measurement of plasma aldosterone concentration (PAC) and plasma renin concentration (PRC) for AAS classification, as well as collection of demographic, clinical, biochemical, anthropometric data and biospecimens for proteomic analysis.
DM group
Participants with diabetes mellitus
Other: observe
A single observational cohort of study participants undergoing baseline biochemical screening for autonomous aldosterone secretion (AAS). No experimental interventions or treatments are administered. All participants receive standard clinical care and undergo standardized baseline assessments, including measurement of plasma aldosterone concentration (PAC) and plasma renin concentration (PRC) for AAS classification, as well as collection of demographic, clinical, biochemical, anthropometric data and biospecimens for proteomic analysis.
AAS group
Participants with autonomous aldosterone secretion (AAS)
Other: observe
A single observational cohort of study participants undergoing baseline biochemical screening for autonomous aldosterone secretion (AAS). No experimental interventions or treatments are administered. All participants receive standard clinical care and undergo standardized baseline assessments, including measurement of plasma aldosterone concentration (PAC) and plasma renin concentration (PRC) for AAS classification, as well as collection of demographic, clinical, biochemical, anthropometric data and biospecimens for proteomic analysis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The prevalence of autonomous secretion of aldosterone
Time Frame: The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years
The primary outcome is the prevalence of autonomous aldosterone secretion at baseline. Autonomous aldosterone secretion is defined by plasma aldosterone concentration (PAC) ≥100 pg/mL combined with plasma renin concentration (PRC) ≤15 uIU/mL in study participants at enrollment. Prevalence will be calculated as the number of participants meeting the above biochemical criteria divided by the total enrolled participants in the target population, presented as percentage with corresponding 95% confidence interval.
The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identification of key risk factors associated with autonomous aldosterone secretion
Time Frame: The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years
To identify independent demographic, clinical, biochemical, and anthropometric risk factors associated with prevalent autonomous aldosterone secretion.Autonomous aldosterone secretion is biochemically defined as plasma aldosterone concentration ≥100 pg/mL and plasma renin concentration ≤15 uIU/mL. Multivariable regression analysis will be applied to evaluate significant associated factors; effect sizes (e.g., odds ratio) with 95% confidence intervals and P-values will be reported.
The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years
Association of autonomous aldosterone secretion with chronic kidney disease and metabolic disorders
Time Frame: The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years
To evaluate the cross-sectional association between biochemically defined autonomous aldosterone secretion and chronic kidney disease as well as metabolic abnormalities in study participants at baseline. AAS is defined as plasma aldosterone concentration ≥100 pg/mL combined with plasma renin concentration ≤15 uIU/mL. Chronic kidney disease and metabolic disorders will be defined according to current clinical guidelines; relevant correlation and regression analyses will be performed to report effect sizes with 95% confidence intervals and P-values.
The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years
Screening of key proteins, signaling pathways and potential biomarkers associated with autonomous aldosterone secretion using proteomic analysis
Time Frame: The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years
To explore differentially expressed key proteins, enriched signaling pathways and candidate molecular biomarkers correlated with biochemical autonomous aldosterone secretion (AAS) via quantitative proteomic technology. AAS is defined as plasma aldosterone concentration ≥100 pg/mL and plasma renin concentration ≤15 uIU/mL. Bioinformatics analyses including protein differential expression profiling, functional enrichment analysis and pathway annotation will be performed to identify core molecular targets and potential diagnostic biomarkers for AAS.
The follow-up period from baseline enrollment to the completion of follow-up examinations was approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qifu Li

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qifu Li, MD, PhD, Chief Physician, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EIMDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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