- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512609
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
Recruiting
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
- 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
-
-
-
Chongqing, China
- Recruiting
- The First Affiliated Hospital of Chongqing Medical University
-
Contact:
- Yunyan Liao, MD
- Phone Number: 15823939745
- Email: 2215133087@qq.com
-
-
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
- 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 |
Intervention / Treatment |
|---|---|
|
hypertension group
Participants with hypertension
|
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
|
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)
|
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
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
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
Investigators
- 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
- Hu Y, Ding M, Sampson L, Willett WC, Manson JE, Wang M, Rosner B, Hu FB, Sun Q. Intake of whole grain foods and risk of type 2 diabetes: results from three prospective cohort studies. BMJ. 2020 Jul 8;370:m2206. doi: 10.1136/bmj.m2206.
- Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.
- Bao Y, Han J, Hu FB, Giovannucci EL, Stampfer MJ, Willett WC, Fuchs CS. Association of nut consumption with total and cause-specific mortality. N Engl J Med. 2013 Nov 21;369(21):2001-11. doi: 10.1056/NEJMoa1307352.
- Ley SH, Hamdy O, Mohan V, Hu FB. Prevention and management of type 2 diabetes: dietary components and nutritional strategies. Lancet. 2014 Jun 7;383(9933):1999-2007. doi: 10.1016/S0140-6736(14)60613-9.
- Chan JC, Malik V, Jia W, Kadowaki T, Yajnik CS, Yoon KH, Hu FB. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA. 2009 May 27;301(20):2129-40. doi: 10.1001/jama.2009.726.
- Li Y, Schoufour J, Wang DD, Dhana K, Pan A, Liu X, Song M, Liu G, Shin HJ, Sun Q, Al-Shaar L, Wang M, Rimm EB, Hertzmark E, Stampfer MJ, Willett WC, Franco OH, Hu FB. Healthy lifestyle and life expectancy free of cancer, cardiovascular disease, and type 2 diabetes: prospective cohort study. BMJ. 2020 Jan 8;368:l6669. doi: 10.1136/bmj.l6669.
- Hu Y, Zong G, Liu G, Wang M, Rosner B, Pan A, Willett WC, Manson JE, Hu FB, Sun Q. Smoking Cessation, Weight Change, Type 2 Diabetes, and Mortality. N Engl J Med. 2018 Aug 16;379(7):623-632. doi: 10.1056/NEJMoa1803626.
- Zhang PP, Han Q, Sheng MX, Du CY, Wang YL, Cheng XF, Xu HX, Li CC, Xu YJ. Identification of Circular RNA Expression Profiles in White Adipocytes and Their Roles in Adipogenesis. Front Physiol. 2021 Aug 19;12:728208. doi: 10.3389/fphys.2021.728208. eCollection 2021.
- Guo X, Zhang Z, Zeng T, Lim YC, Wang Y, Xie X, Yang S, Huang C, Xu M, Tao L, Zeng H, Sun L, Li X. cAMP-MicroRNA-203-IFNgamma network regulates subcutaneous white fat browning and glucose tolerance. Mol Metab. 2019 Oct;28:36-47. doi: 10.1016/j.molmet.2019.07.002. Epub 2019 Jul 6.
- Arner P, Kulyte A. MicroRNA regulatory networks in human adipose tissue and obesity. Nat Rev Endocrinol. 2015 May;11(5):276-88. doi: 10.1038/nrendo.2015.25. Epub 2015 Mar 3.
- Mulatero P, Monticone S, Burrello J, Veglio F, Williams TA, Funder J. Guidelines for primary aldosteronism: uptake by primary care physicians in Europe. J Hypertens. 2016 Nov;34(11):2253-7. doi: 10.1097/HJH.0000000000001088.
- Chen X, Mao Y, Hu J, Han S, Gong L, Luo T, Yang S, Qing H, Wang Y, Du Z, Mei M, Zheng L, Lv X, Tang Y, Zhao Q, Zhou Y, He JC, Li Q, Wang Z. Perirenal Fat Thickness Is Significantly Associated With the Risk for Development of Chronic Kidney Disease in Patients With Diabetes. Diabetes. 2021 Oct;70(10):2322-2332. doi: 10.2337/db20-1031. Epub 2021 Jun 22.
- Hu J, Yang S, Zhang A, Yang P, Cao X, Li X, Goswami R, Wang Y, Luo T, Liao K, Cheng Q, Xiao X, Li Q. Abdominal Obesity Is More Closely Associated With Diabetic Kidney Disease Than General Obesity. Diabetes Care. 2016 Oct;39(10):e179-80. doi: 10.2337/dc16-1025. Epub 2016 Aug 18. No abstract available.
- Hu J, Hu Y, Hertzmark E, Yuan C, Liu G, Stampfer MJ, Rimm EB, Hu FB, Wang M, Sun Q. Weight Change, Lifestyle, and Mortality in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Feb 17;107(3):627-637. doi: 10.1210/clinem/dgab800.
- Hu FB, Satija A, Manson JE. Curbing the Diabetes Pandemic: The Need for Global Policy Solutions. JAMA. 2015 Jun 16;313(23):2319-20. doi: 10.1001/jama.2015.5287. No abstract available.
- Tobias DK, Pan A, Jackson CL, O'Reilly EJ, Ding EL, Willett WC, Manson JE, Hu FB. Body-mass index and mortality among adults with incident type 2 diabetes. N Engl J Med. 2014 Jan 16;370(3):233-44. doi: 10.1056/NEJMoa1304501.
- Grontved A, Hu FB. Television viewing and risk of type 2 diabetes, cardiovascular disease, and all-cause mortality: a meta-analysis. JAMA. 2011 Jun 15;305(23):2448-55. doi: 10.1001/jama.2011.812.
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 25, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 20, 2025
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 6, 2026
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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