Sodium Storage in Singaporeans (SSIS)
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|ClinicalTrials.gov Identifier: NCT04319068|
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
|Condition or disease|
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|
|Estimated Enrollment :||600 participants|
|Official Title:||Sodium Storage in Singaporeans|
|Actual Study Start Date :||July 2, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
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
- 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
- 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)
- 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
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319068
|Contact: Adriana Marton, MD||6516 email@example.com|
|Contact: TzyTiing Lim, BSCfirstname.lastname@example.org|
|National Heart Centre Singapore||Recruiting|
|Singapore, Singapore, 169609|
|Contact: Katherina Oh email@example.com|
|Principal Investigator: Calvin Chin, MD|
|Duke-NUS Medical School||Active, not recruiting|
|Singapore, Singapore, 169857|