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The Study of Urinary Biomarkers in Patients With Hypomagnesemia

The Study of Urinary Biomarkers in Patients With Hypomagnesemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07056283
Enrollment
15
Registered
2025-07-09
Start date
2025-07-31
Completion date
2027-06-30
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypomagnesemia

Keywords

Hypomagnesemia, Magnesium

Brief summary

In this pilot exploratory study, we aim to examine extracellular vesicles (EVs) as biomarkers in urine from up to 15 patients, with up to 10 samples per patient among the patients with a history of hypomagnesemia.

Detailed description

Various medications (amiloride, SGLT2 inhibitors, calcineurin inhibitors) and medical conditions (type 2 diabetes mellitus, genetic factors) are associated with changes in blood magnesium levels, primarily by affecting magnesium transport in different regions of the kidney tubules. Over the past two decades, the discovery of extracellular vesicles (EVs) in urine has led to the emergence of a rapidly growing scientific field, offering an excellent non-invasive source for studying renal physiology. In this exploratory pilot study, we aim to enhance the mechanistic understanding of magnesium homeostasis by conducting noninvasive multi-omics (i.e., lipidomics, microRNAomics, and phospho-proteomics) research using urinary extracellular vesicles (uEVs) as biomarkers among patients with a history of hypomagnesemia. Fasting and post-magnesium-rich meal morning urine samples (6 am to 12 pm) will be collected at various intervals, depending on the most recent serum magnesium levels available during the study period. We will examine biomarkers capable of dissecting the mechanisms of hypomagnesemia.

Interventions

None listed

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Adult (≥18 years old) * History of hypomagnesemia (serum Mg \<1.7 mg/dL)

Exclusion criteria

* Current or recent use of loop, thiazide, or thiazide-like diuretics within the last 3 months

Design outcomes

Primary

MeasureTime frame
Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin2 years

Countries

United States

Contacts

Primary ContactChintan Shah, MD
shahc@ufl.edu(352) 294-8790

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026