Sodium Storage in Singaporeans (SSIS)

August 1, 2024 updated by: Jens Titze
The overarching hypothesis of this study is that the kidney and the skin form an integrative network for water conservation, where Na+ storage is utilized to prevent body water loss, even at the expense of increased cardiovascular risk. The aim of this project is to characterise skin and muscle Na+ storage in a cohort designed to prospectively measure cardiovascular outcomes in Singaporeans, in order to determine whether humans with increased tissue Na+ storage have increased cardiovascular risk. To gain a better understanding of the mechanisms behind Na+ storage, the investigators will also test the hypothesis that participants with mutations of the skin protein filaggrin, who have increased water loss through the skin, will have increased skin Na+ storage and higher blood pressure levels.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Cardiovascular disease (CVD) occurs with increasing age and is the leading cause of death worldwide. A causal relationship between salt and CVD, although well established in animal models, has been difficult to prove in human populations. First, because humans do not live under the strict experimental conditions necessary to quantify sodium intake, and second, because tissue sodium stores cannot be detected with the available clinical methods, making reliable measurements of total body sodium extremely challenging.

The investigators have previously implemented 23NaMRI technology to detect and quantify tissue Na+ stores in humans. Previous studies have sown that humans store large amounts of Na+ in their skin and muscle as they age and that skin Na+ storage is linked with hypertension, while muscle Na+ storage is coupled with insulin resistance and diabetes. More recent studies show that the adverse effect of Na+ on human health goes far beyond the well-established salt-blood pressure relationship. The investigators have found that urea and/or Na+ storage in barriers such as kidney or skin is a key principle of water conservation.

This study aims to test the hypothesis that water conservation in the skin is essential for systemic fluid and blood pressure homeostasis, and that skin Na+ storage is utilized to prevent water loss, even at the expense of increased cardiovascular risk.

This is a cross-sectional study design with one study visit and a recruitment period of 3 years. 600 participants will be recruited from the Biobank cohort and tissue Na+ will be measured using 23NaMRI. The study will test whether increased Na+ storage in the skin is coupled with transepidermal water loss at the expense of high blood pressure levels, and examine the association between tissue sodium storage and specific cardiovascular markers.

Study Type

Observational

Enrollment (Estimated)

600

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

  • Singapore
      • Singapore, Singapore, 169609
        • National Heart Centre Singapore
      • Singapore, Singapore, 169857
        • Duke-NUS Medical School

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Eligible participants from the Biobank cohort at the National Heart Centre, Singapore, will be screened and estimated 600 subjects (healthy controls and hypertensive patients) will be recruited for the study over a period of 3 years. No ethnic group or gender is targeted for or excluded from this reasearch.

Description

Inclusion Criteria:

  1. Participants from the Biobank (Molecular and Imaging Studies of Cardiovascular Health and Disease) cohort in Singapore, who agreed to be contacted for further studies
  2. Male and female patients older than 21 years
  3. Willingness to participate and ability to provide informed consent

Exclusion Criteria:

  1. Patients with exclusion criteria for the MRI, such as:

    1. implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants)
    2. iron-based tattoos
    3. any other pieces of metal or devices that are not MR-Safe anywhere in the body
    4. patients who exhibit noticeable anxiety and/or claustrophobia into the MRI scanner
  2. Pregnant women
  3. Diagnosis of heart failure NYHA classes III and IV
  4. Impaired renal function with eGFR<45 ml/min or proteinuria > 0.5 g/24h
  5. Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia
  6. Peripheral oedema as assessed by the investigator
  7. Active cancer
  8. Patients who have received an organ or bone marrow transplant
  9. Patients who have had major surgery in the past 3 months
  10. Patients who have severe comorbid conditions likely to compromise survival or study participation
  11. Unwillingness or other inability to cooperate

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Healthy
Eligible participants from the Biobank cohort at the National Heart Centre, Singapore, will be screened will be recruited for the study over a period of 3 years.
Hypertensive
Eligible participants from the Biobank cohort at the National Heart Centre, Singapore, will be screened will be recruited for the study over a period of 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin and muscle Na+ content
Time Frame: 3 years
Differences in skin and muscle Na+ content (measured with 23NaMRI) between healthy participants and hypertensive patients, overall and according to age, gender and race/ethnicity
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between skin water loss and skin Na+ content
Time Frame: 3 years
To show that participants with high transepidermal water loss (measured with Tewameter TM300) have higher skin sodium content (measured with 23NaMRI)
3 years
Skin water loss in hypertensive participants
Time Frame: 3 years
To show that hypertensive participants have higher transepidermal water loss (measured with Tewameter TM300) and higher skin Na+ content than healthy participants
3 years

Collaborators and Investigators

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

Sponsor

Jens Titze

Collaborators

National Heart Centre Singapore

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)

July 2, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 22, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSiS

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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