How Seasons Affect Kidney Health in Post-Menopausal Females

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.

Study Overview

• Status: Completed
• Conditions: Female; Postmenopausal
• Intervention / Treatment: Other: There will be no intervention.

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the greater Tallahassee, Florida area.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Winter; Assessment of the cohort in winter 2025 (visit 1).	Other: 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.
Summer; Assessment of the cohort in summer 2025 (visit 2).	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma neutrophil gelatinase-associated lipocalin (NGAL)	Changes in NGAL will be measured in blood samples using enzyme-linked immunosorbent assay.	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.	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.	Visit 1 (0 months) and Visit 2 (7 months)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Joseph Watso, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Older Adults; Hydration; Aging; Postmenopausal Women; Post-Menopause; Heat Stress; Kidney Health
• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders
• Other Study ID Numbers: STUDY00005199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
• IPD Sharing Time Frame: One year after completion of the trial, indefinitely
• IPD Sharing Access Criteria: A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No