How Seasons Affect Kidney Health in Post-Menopausal Females

Recruiting

• Conditions: Postmenopausal; Female

• Registration Number: NCT06866743
• Lead Sponsor: Florida State University

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.

Study Timeline

• Study Start: 2025-01-03
• Study First Submitted: 2025-02-14
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-09-07
• Study Completion: 2025-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma neutrophil gelatinase-associated lipocalin (NGAL)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
estimated glomerular filtration rate (eGFR)	Visit 1 (0 months) and Visit 2 (7 months)	eGFR will be calculated from creatinine using CKD-EPI equation.

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States