The Study of Urinary Biomarkers in Patients With Hypomagnesemia

University of Florida

Status: Enrolling

Conditions: Hypomagnesemia

Study type: Observational

Funder types: Other

Identifiers

NCT07056283

IRB202500405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Hypomagnesemia (serum Mg <1.7 mg/dL)

Description:

The patients will be selected with a history of hypomagnesemia. The urine samples will be collected at various intervals depending on the most recent serum magnesium levels available during the study period. The patients may or may not be on medications known to alter serum magnesium levels.