Clinical trial NCT06866743: How Seasons Affect Kidney Health in Post-Menopausal Females
Official title: Seasonal Changes in Kidney Function Among Female Adults Post-Menopause
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postmenopausal
Female
Keywords: Kidney Health
Post-Menopause
Heat Stress
Hydration
Older Adults
Aging
Postmenopausal Women
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the greater Tallahassee, Florida area.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Female aged ≥55 years old
* Self Reported as at least one year post-menopause
* Live in Tallahassee, Florida, or the surrounding area

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Plasma neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: Visit 1 (0 months) and Visit 2 (7 months)
measure: Urinary neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: Visit 1 (0 months) and Visit 2 (7 months)
measure: Insulin-like growth factor-binding protein 7 (IGFBP7)*Tissue inhibitor of metalloproteinase-2 (TIMP-2)
timeFrame: Visit 1 (0 months) and Visit 2 (7 months)
Secondary outcomes:
measure: estimated glomerular filtration rate (eGFR)
timeFrame: Visit 1 (0 months) and Visit 2 (7 months)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Joseph Watso, PhD
role: PRINCIPAL_INVESTIGATOR
References: