HypomagnesemiaNCT07056283
The Study of Urinary Biomarkers in Patients With Hypomagnesemia
An observational study of Hypomagnesemia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypomagnesemia
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic patients at Shands Hospital, Gainesville, Florida, USA.
Who may be able to join
- Adult (≥18 years old)
- History of hypomagnesemia (serum Mg <1.7 mg/dL)
Who cannot join
- Current or recent use of loop, thiazide, or thiazide-like diuretics within the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Chintan Shah, MD, 325-273-8821, shahc@ufl.edu
shahc@ufl.edu
About this study
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.
Read the 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.
- Conditions
- Hypomagnesemia
- Keywords
- Hypomagnesemia, Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start31 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypomagnesemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chintan Shah, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056283
- Sponsor's protocol ID
- IRB202500405
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34944449Lopez 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.
PubMed 36499728Glover 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.
PubMed 31803861Scindia 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.
PubMed 36830842Schramm 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.
PubMed 38791000Aly 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.
PubMed 38499276Pekkucuksen 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.
PubMed 36374911
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Urinary Biomarkers in Patients With Hypomagnesemia
- ClinicalTrials.gov ID
- NCT07056283
- Acronym / sponsor ID
- IRB202500405
- Conditions
- Hypomagnesemia
- Keywords
- Hypomagnesemia, Magnesium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic patients at Shands Hospital, Gainesville, Florida, USA.
Key inclusion criteria (2 listed)
- Adult (≥18 years old)
- History of hypomagnesemia (serum Mg <1.7 mg/dL)
Key exclusion criteria (1 listed)
- Current or recent use of loop, thiazide, or thiazide-like diuretics within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 34944449Chacko 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.
- Background: PubMed 36499728Lopez 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.
- Background: PubMed 31803861Glover 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.
- Background: PubMed 36830842Scindia 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.
- Background: PubMed 38791000Schramm 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.
- Background: PubMed 38499276Aly 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.
- Background: PubMed 36374911Pekkucuksen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chintan Shah, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypomagnesemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chintan Shah, MD ((352) 294-8790, shahc@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07056283, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.