Study on Kidney Disease and EnviromenTal Chemical

December 21, 2020 updated by: Jung Pyo Lee, Seoul National University Hospital

Change of Environmental Chemical Exposures and Prevalence of Chronic Kidney Disease After Epidemiological Spread of SARS-CoV-2 (COVID-19)

  1. Purpose: To confirm the changes in lifestyle due to differences in perceptions of infectious disease risk after the COVID-19 pandemic, decrease in exposure levels of environmentally hazardous chemicals and changes in indicators related to chronic kidney disease

  2. Methods:

    • Survey on health risk awareness and lifestyle for COVID-19
    • Blood and urine tests for exposure to environmentally hazardous chemicals
    • Collection of hospital clinical data utilization for indicators related to chronic kidney disease

  3. Clinical endpoints:

    • Verification of differences in health risk perception level and lifestyle changes
    • Verification of changes in lifestyle changes and exposure to environmentally hazardous chemicals
    • Verification of changes in indicators related to kidney disease according to changes in exposure to environmentally hazardous chemicals
  4. Statistical methods: chi-square test, independent mean comparison t-test, ANOVA test, regression analysis

Study Overview

Status

Status

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

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.

Detailed Description

  1. Background In daily life, people are exposed to various environmental hormones (Endocrine Disrupting Chemicals) such as phthalates, bisphenols, heavy metals, and perfluorinated compounds. Due to the recent pandemic of the COVID-19, behavior patterns such as wearing a mask and refraining from going out in daily life have changed. Such behavioral changes have the potential to change the level of exposure to environmental hazards, like intervention studies. In addition, studies have been reported that exposure to various environmental hormones can affect kidney function, but epidemiological studies are insufficient. Therefore, the research team is trying to determine whether exposure to environmental hormones changes due to changes in behavioral patterns according to the new corona epidemic, and to determine the effect on renal function indices in patients with chronic kidney disease.

  2. Hypothesis and Purpose

    • Differences in risk perception for disease after the COVID-19 pandemic can explain the degree of change in lifestyle.
    • The changed lifestyle will lead to reduced exposure to environmentally hazardous substances.
    • Reduction of exposure to environmentally harmful substances will reduce the level of exposure to harmful substances related to kidney disease, which will lead to changes in the prevalence of kidney disease and indicators related to kidney disease.
    • After the COVID-19 pandemic, it is verified whether the exposure level of environmentally hazardous chemicals decreases due to changes in the way of life and differences in perception of the risk of infectious diseases, and confirms which indicators related to chronic kidney disease change accordingly. Identify the role.

  3. Methods (1) During the COVID-19 pandemic

    • Acquisition of consent (using explanations and posters) by explaining the research purpose and method
    • Survey on changes in awareness of diseases and changes in hygiene activities since the COVID-19 pandemic compared to before
    • Measurement of the concentration of environmentally hazardous substances through the acquisition of blood (serum, residual samples after blood tests for treatment) and urine samples that are normally performed in the office (3 months cycle, 4 times)
    • Acquisition of clinical information related to kidney disease (2) Recovery period of the COVID-19 pandemic
    • Survey on changes in awareness of diseases and hygiene activities that have changed since the end of the COVID-19 outbreak
    • Measurement of the concentration of environmentally harmful substances by obtaining blood (serum, residual sample after blood test for medical treatment) and urine sample (once after 6 months of termination)

    • Acquisition of clinical information related to kidney disease (3) Investigation variable

      a) Survey

    • Demographic information
    • Anthropometric information
    • Risk perception for the COVID-19
    • Individual behavior associated with hygiene
    • Social distancing pattern b) Chemical material in human sample (blood, urine)
    • Phthalate metabolite
    • Paraben metabolite
    • Benzophenone
    • Triclosan and triclocarban
    • Bisphenols
    • Phosphate metabolites
    • Organochlorine pesticides
    • Polychlorinated biphenyls c) Clinical information including estimated glomerular filtration rate, urine protein/creatinine ratio

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 (Anticipated)

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.
310

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.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • 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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Target number: around 310
  • The total number of participants in the study is around 300-350. In order to figure outcomes, data from the Basic Survey on National Environmental Health were used, and the preceding study (intervention study) was referred to.
  • In multiple regression analysis, the correlation between eGFR and ethylparaben (EtP) was examined by adjusting age, BMI, smoking history, and drinking history. In the full model, where all variables were corrected, R2 was 0.478, and when the independent variable EtP was excluded, R2 decreased by 0.012. Based on these values, as a result of setting the power of 0.7, 0.8, and 0.9 in the multiple regression model, n = 283, 359, and 479, respectively. Based on this result, the number of study participants was set to around 300-350.

Description

Inclusion Criteria:

  • aged 19 years or older
  • who have been treated twice or more with chronic kidney disease as their main diagnosis in an outpatient department of kidney medicine for more than 3 months

Exclusion Criteria:

  • Patients who do not observe the rapid deterioration of renal function (AKI)
  • Patients who are likely to significantly change their lifestyle and exposure levels of environmentally hazardous chemicals due to the rapid progression of the disease itself, accompanied by the following chronic diseases (malignant tumors, dementia, immunosuppressants Use, stroke within 1 year, cerebral hemorrhage, myocardial infarction)
  • Other patients who have difficulty in general communication or who are unable to carry out their daily life on their own

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

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
Identification of environmental hazard exposure levels and influencing factors
Time Frame: From initial recruitment to after 21 (+/- 3) months
  • Collecting and organizing survey data
  • Calculation of technical statistics on exposure to major environmental hazards
  • Identification of determinants affecting the exposure level of environmentally hazardous substances
From initial recruitment to after 21 (+/- 3) months
Relationship between exposure and health related behavior change
Time Frame: From initial recruitment to after 21 (+/- 3) months
  • Analysis of correlation of kidney disease occurrence according to exposure to harmful substances
  • Identify the possibility of health effects from exposure to environmentally harmful factors such as disease prevalence, glomerular filtration rate, and urine protein/creatinine ratio according to the definition of chronic kidney disease.
From initial recruitment to after 21 (+/- 3) months

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.
Seoul National University Hospital

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: Jung Pyo Lee, M.D., Ph.D., SMG-SNU Boramae Medical Center

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.
June 1, 2020

Primary Completion (Anticipated)

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, 2021

Study Completion (Anticipated)

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, 2021

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).
December 17, 2020

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.
December 20, 2020

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.
December 22, 2020

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.
December 23, 2020

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.
December 21, 2020

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.
December 1, 2020

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.
  • SKETCH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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