Skip to main content
OpenTrials
Completed

NCT Number: NCT06866743

How Seasons Affect Kidney Health in Post-Menopausal Females

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. estimated glomerular filtration rate (eGFR)

    Time frame: Visit 1 (0 months) and Visit 2 (7 months)

    eGFR will be calculated from creatinine using CKD-EPI equation.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Seasonal Changes in Kidney Function Among Female Adults Post-Menopause

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.