PostmenopausalNCT06866743
How Seasons Affect Kidney Health in Post-Menopausal Females
An observational study of Postmenopausal and Female, run by Florida State University at 1 site in United States.
Trial summary
The investigators are assessing how seasonal changes affect kidney function biomarkers in post-menopausal women, an understudied group. While heat stress can reduce kidney function, previous research has not accounted for physical activity, diet, hydration, or sun exposure. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Postmenopausal, Female
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 3 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the greater Tallahassee, Florida area.
Who may be able to join
- Female aged ≥55 years old
- Self Reported as at least one year post-menopause
- Live in Tallahassee, Florida, or the surrounding area
Who cannot join
- Have a BMI of ≥30 kg/m2
- Systolic blood pressure of ≥140 and/or diastolic blood pressure ≥90 mmHg
- Self Reported Current or recent (regular use within the past six months) use of a diuretic medication
- Self Reported: Uncontrolled cardiovascular, respiratory, neurological, renal, liver, or metabolic health condition
- Current or recent (regular use within the past six months) use of tobacco, nicotine, nonsteroidal anti-inflammatory products
- No regular (≥once per week) purposeful heat exposure (e.g., sauna, spa, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Seasonal Changes in Kidney Function Among Female Adults Post-Menopause
The investigators are assessing how seasonal changes affect kidney function biomarkers in post-menopausal women, an understudied group. While heat stress can reduce kidney function, previous research has not accounted for physical activity, diet, hydration, or sun exposure.
Read the detailed description
Intense heat stress on the body can reduce kidney function. A recent study reported that blood markers of kidney function are lower among people in hotter climates. However, these data did not consider physical activity, food intake, fluid intake, time spent outdoors, or exposure to sunlight. Therefore, the investigators invite participants to help determine whether there are seasonal changes in kidney function biomarkers. This will also help the investigators understand if physical activity, food intake, fluid intake, time spent outdoors, or exposure to sunlight affect kidney function biomarkers between seasons. The investigators are studying female adults post-menopause since they are an understudied group.
- Conditions
- Postmenopausal, Female
- Being tested
- There will be no intervention.
- Keywords
- Kidney Health, Post-Menopause, Heat Stress, Hydration, Older Adults, Aging, Postmenopausal Women
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There will be no intervention.Other
This research focuses on examining seasonal variations in kidney function among postmenopausal females. As an observational study, our approach is non-interventional.
| Study group | Role | What they receive |
|---|---|---|
| Winter | Assessment of the cohort in winter 2025 (visit 1). Receives: Other: There will be no intervention. | |
| Summer | Assessment of the cohort in summer 2025 (visit 2). Receives: Other: There will be no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma neutrophil gelatinase-associated lipocalin (NGAL)
Changes in NGAL will be measured in blood samples using enzyme-linked immunosorbent assay.
Measured: Visit 1 (0 months) and Visit 2 (7 months)
Urinary neutrophil gelatinase-associated lipocalin (NGAL)
Changes in NGAL will be measured in urine samples using radioimmunoassay.
Measured: Visit 1 (0 months) and Visit 2 (7 months)
Insulin-like growth factor-binding protein 7 (IGFBP7)*Tissue inhibitor of metalloproteinase-2 (TIMP-2)
The product of Insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinase-2 (TIMP-2) will be measured in blood samples using enzyme-linked immunosorbent assays.
Measured: Visit 1 (0 months) and Visit 2 (7 months)
Secondary outcomes (1)
estimated glomerular filtration rate (eGFR)
eGFR will be calculated from creatinine using CKD-EPI equation.
Measured: Visit 1 (0 months) and Visit 2 (7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start3 Jan 2025
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Watso, Florida State University
- Investigators
- Joseph Watso, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866743
- Sponsor's protocol ID
- STUDY00005199
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Changes in Kidney Function Among Female Adults Post-Menopause
- ClinicalTrials.gov ID
- NCT06866743
- Acronym / sponsor ID
- STUDY00005199
- Conditions
- Postmenopausal, Female
- Keywords
- Kidney Health, Post-Menopause, Heat Stress, Hydration, Older Adults, Aging, Postmenopausal Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 10 Mar 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.
The investigators are assessing how seasonal changes affect kidney function biomarkers in post-menopausal women, an understudied group. While heat stress can reduce kidney function, previous research has not accounted for physical activity, diet, hydration, or sun exposure.
Detailed description
Intense heat stress on the body can reduce kidney function. A recent study reported that blood markers of kidney function are lower among people in hotter climates. However, these data did not consider physical activity, food intake, fluid intake, time spent outdoors, or exposure to sunlight. Therefore, the investigators invite participants to help determine whether there are seasonal changes in kidney function biomarkers. This will also help the investigators understand if physical activity, food intake, fluid intake, time spent outdoors, or exposure to sunlight affect kidney function biomarkers between seasons. The investigators are studying female adults post-menopause since they are an understudied group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Winter | – | Other: There will be no intervention.Assessment of the cohort in winter 2025 (visit 1). |
| Summer | – | Other: There will be no intervention.Assessment of the cohort in summer 2025 (visit 2). |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the greater Tallahassee, Florida area.
Key inclusion criteria (3 listed)
- Female aged ≥55 years old
- Self Reported as at least one year post-menopause
- Live in Tallahassee, Florida, or the surrounding area
Key exclusion criteria (6 listed)
- Have a BMI of ≥30 kg/m2
- Systolic blood pressure of ≥140 and/or diastolic blood pressure ≥90 mmHg
- Self Reported Current or recent (regular use within the past six months) use of a diuretic medication
- Self Reported: Uncontrolled cardiovascular, respiratory, neurological, renal, liver, or metabolic health condition
- Current or recent (regular use within the past six months) use of tobacco, nicotine, nonsteroidal anti-inflammatory products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There will be no intervention.This research focuses on examining seasonal variations in kidney function among postmenopausal females. As an observational study, our approach is non-interventional. | Other | Summer, Winter |
Primary outcome
Plasma neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: Visit 1 (0 months) and Visit 2 (7 months)
Changes in NGAL will be measured in blood samples using enzyme-linked immunosorbent assay.
Urinary neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: Visit 1 (0 months) and Visit 2 (7 months)
Changes in NGAL will be measured in urine samples using radioimmunoassay.
Insulin-like growth factor-binding protein 7 (IGFBP7)*Tissue inhibitor of metalloproteinase-2 (TIMP-2)
Time frame: Visit 1 (0 months) and Visit 2 (7 months)
The product of Insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinase-2 (TIMP-2) will be measured in blood samples using enzyme-linked immunosorbent assays.
1 secondary outcome
estimated glomerular filtration rate (eGFR)
Time frame: Visit 1 (0 months) and Visit 2 (7 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
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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. This study is not recruiting at the moment.
Joseph Watso, PhD principal investigator
Florida State University
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 Postmenopausal and Female, run by Florida State University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma neutrophil gelatinase-associated lipocalin (NGAL) (time frame: Visit 1 (0 months) and Visit 2 (7 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2025.