NCT07056283

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
13mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2025Jun 2027

First Submitted

Initial submission to the registry

June 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

June 29, 2025

Last Update Submit

August 19, 2025

Conditions

Hypomagnesemia

Keywords

HypomagnesemiaMagnesium

Outcome Measures

Primary Outcomes (1)

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

    2 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinic patients at Shands Hospital, Gainesville, Florida, USA.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 34944449BACKGROUND

  • 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.

    PMID: 36499728BACKGROUND

  • 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.

    PMID: 31803861BACKGROUND

  • 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.

    PMID: 36830842BACKGROUND

  • 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.

    PMID: 38791000BACKGROUND

  • 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.

    PMID: 38499276BACKGROUND

  • 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.

    PMID: 36374911BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

Study Officials

  • Chintan Shah, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chintan Shah, MD

CONTACT

(352) 294-8790shahc@ufl.edu

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 9, 2025

Study Start

July 31, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)