The Study of Urinary Biomarkers in Patients With Hypomagnesemia

NCT ID: NCT07056283

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Hypomagnesemia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypomagnesemia (serum Mg <1.7 mg/dL)

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chintan Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chintan Shah, MD

Role: CONTACT

(352) 294-8790

Facility Contacts

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Chintan Shah, MD

Role: primary

325-273-8821

Role: backup

References

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Chacko KM, Nouri MZ, Schramm WC, Malik Z, Liu LP, Denslow ND, Alli AA. Tempol Alters Urinary Extracellular Vesicle Lipid Content and Release While Reducing Blood Pressure during the Development of Salt-Sensitive Hypertension. Biomolecules. 2021 Dec 1;11(12):1804. doi: 10.3390/biom11121804.

Reference Type BACKGROUND
PMID: 34944449 (View on PubMed)

Lopez JP, Nouri MZ, Ebrahim A, Chacko KM, Schramm WC, Gholam MF, Ozrazgat-Baslanti T, Denslow ND, Alli AA. Lipid Profiles of Urinary Extracellular Vesicles Released during the Inactive and Active Phases of Aged Male Mice with Spontaneous Hypertension. Int J Mol Sci. 2022 Dec 6;23(23):15397. doi: 10.3390/ijms232315397.

Reference Type BACKGROUND
PMID: 36499728 (View on PubMed)

Glover SC, Nouri MZ, Tuna KM, Mendoza Alvarez LB, Ryan LK, Shirley JF, Tang Y, Denslow ND, Alli AA. Lipidomic analysis of urinary exosomes from hereditary alpha-tryptasemia patients and healthy volunteers. FASEB Bioadv. 2019 Oct;1(10):624-638. doi: 10.1096/fba.2019-00030. Epub 2019 Aug 24.

Reference Type BACKGROUND
PMID: 31803861 (View on PubMed)

Scindia YM, Gholam MF, Waleed A, Liu LP, Chacko KM, Desai D, Lopez JP, Malik Z, Schramm WC, Morales AG, Carson-Marino M, Alli AA. Metformin Alleviates Diabetes-Associated Hypertension by Attenuating the Renal Epithelial Sodium Channel. Biomedicines. 2023 Jan 21;11(2):305. doi: 10.3390/biomedicines11020305.

Reference Type BACKGROUND
PMID: 36830842 (View on PubMed)

Schramm WC, Bala N, Arekar T, Malik Z, Chacko KM, Lewis RL, Denslow ND, Scindia Y, Alli AA. Enrichment of Bioactive Lipids in Urinary Extracellular Vesicles and Evidence of Apoptosis in Kidneys of Hypertensive Diabetic Cathepsin B Knockout Mice after Streptozotocin Treatment. Biomedicines. 2024 May 8;12(5):1038. doi: 10.3390/biomedicines12051038.

Reference Type BACKGROUND
PMID: 38791000 (View on PubMed)

Aly R, Darwish S, Bala N, Ebrahim A, Shoemaker LR, McCray J, Garrett TJ, Alli AA. Functional and metabolomic analysis of urinary extracellular vesicles from juvenile mice with renal compensatory hypertrophy. Biochim Biophys Acta Mol Basis Dis. 2024 Jun;1870(5):167096. doi: 10.1016/j.bbadis.2024.167096. Epub 2024 Mar 16.

Reference Type BACKGROUND
PMID: 38499276 (View on PubMed)

Pekkucuksen NT, Liu LP, Aly R, Shoemaker LR, Alli AA. Extracellular vesicles from focal segmental glomerulosclerosis pediatric patients induce STAT3 activation and mesangial cell proliferation. PLoS One. 2022 Nov 14;17(11):e0274598. doi: 10.1371/journal.pone.0274598. eCollection 2022.

Reference Type BACKGROUND
PMID: 36374911 (View on PubMed)

Other Identifiers

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IRB202500405

Identifier Type: -

Identifier Source: org_study_id

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