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Clinical Trials/NCT07056283
NCT07056283RecruitingNot Applicable

The Study of Urinary Biomarkers in Patients With Hypomagnesemia

University of Florida1 site in 1 country15 target enrollmentStarted: July 31, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
15
Locations
1
Primary Endpoint
Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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