Urine extracellular vesicle biomarkers for people with low magnesium

The Study of Urinary Biomarkers in Patients With Hypomagnesemia

We will test whether tiny particles in urine can reveal the kidney-related causes of low blood magnesium in adults with hypomagnesemia.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT07056283 on ClinicalTrials.gov

What this trial studies

This is a small, noninvasive pilot study collecting morning urine from up to 15 adults with a history of low blood magnesium, with up to 10 samples per person. Investigators will isolate urinary extracellular vesicles (uEVs) and perform multi-omics analyses including lipidomics, microRNA profiling, and phospho-proteomics to look for signatures linked to magnesium handling. Samples will include fasting and post–magnesium-rich meal collections taken in the morning, timed around recent serum magnesium measurements. The goal is to use uEV biomarkers to better understand renal mechanisms that cause hypomagnesemia.

Who should consider this trial

Good fit: Adults aged 18 or older with a documented history of hypomagnesemia (serum Mg < 1.7 mg/dL) who can provide multiple morning urine samples and are not taking excluded diuretics are ideal candidates.

Not a fit: People currently taking loop, thiazide, or thiazide-like diuretics within the past three months, or those without documented low magnesium, are unlikely to receive direct benefit from this observational biomarker study.

Why it matters

Potential benefit: If successful, this approach could lead to a noninvasive urine test that helps pinpoint why a person is losing magnesium and guide more personalized treatment.

How similar studies have performed: Urinary extracellular vesicles have shown promise as biomarkers in other kidney research, but applying multi-omics specifically to explain hypomagnesemia is relatively novel and largely untested.

Eligibility criteria

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

Where this trial is running

Gainesville, Florida

• University of Florida — Gainesville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Chintan Shah, MD — University of Florida
• Study coordinator: Chintan Shah, MD

Conditions Hypomagnesemia; Magnesium