How Seasons Affect Kidney Health in Post-Menopausal Females

NCT06866743 | Completed

• 1 other identifier: STUDY00005199
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal; Female

Keywords

Kidney Health; Post-Menopause; Heat Stress; Hydration; Older Adults; Aging; Postmenopausal Women

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• estimated glomerular filtration rate (eGFR)

  Visit 1 (0 months) and Visit 2 (7 months)

Study Arms (2)

Winter

Assessment of the cohort in winter 2025 (visit 1).

Other: There will be no intervention.

Summer

Assessment of the cohort in summer 2025 (visit 2).

Other: There will be no intervention.

Interventions

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.

Summer; Winter

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and urine samples

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Joseph Watso, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 10, 2025
• Study Start: January 3, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after completion of the trial, indefinitely
• 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.

Locations

US (1)