Kidney Function in Obese Women

Kidney Function Markers in Postmenopausal Obese Women: Response to Aerobic Training

The goal of this clinical trial is to investigate the impact of a 10-week moderate intensity interval walking training (MIIWT) program on kidney function markers in obese postmenopausal women. The main question it aims to answer is:

Does MIIWT improve kidney function markers in this population? Researchers will compare MIIWT (designed to training group) to non-training intervention (designed to control group) to see if the training program works to improve kidney function markers.

Participants in training group will: perform a 10-week MIIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in control group will : not perform any physical training and maintain their usual daily activities.

Study Overview

• Status: Completed
• Conditions: Kidney Function Tests
• Intervention / Treatment: Behavioral: walking intervention

Detailed Description

The convergence of the obesity pandemic and the postmenopausal status is likely associated with renal function decline. Regular aerobic training have been shown to prevent adverse health outcomes in obese. The main purpose of this study was to evaluate changes in kidney function markers and white blood cell (WBC) subpopulations in obese postmenopausal women participating in moderate intensity interval walking training (MIIWT). A total of 36 obese postmenopausal women were randomized to MIIWT (CON, n=18) or control group (CON, n=18), four times a week for 10-week. The MIIWT consisted on 5 repetitions of walking for 6-min at 60-80% of the 6-min-walk-test-distance with 6-min of active recovery between repetitions. Before and after the MIIWT, body composition, kidney function markers (serum creatinine [sCr], blood urea nitrogen [BUN], serum uric acid [sUA] and Glomerular Filtration Rate [GFR] and white blood cells (WBC) count and its specific subpopulations (neutrophils [NEU], lymphocytes [LYM], monocytes [MON], eosinophils [EOSI] and basophils [BASO]) were assessed.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Kef
    • Boulifa, Kef, Tunisia, 7100
      • High Institute of Sports and Physical Education of Kef

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• be aged between 50 and 60 years.
• be postmenopausal (absence of menses > 12 months).
• present a BMI greater than or equal to 30 kg/m2.
• be free of any special diets in the three months prior to the start of the intervention.
• have a sedentary lifestyle (exercise less than 2 h/week).

Exclusion Criteria:

• Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
• Being under menopausal hormone therapy.
• Presenting any orthopedic limitations interfering the ability to perform the study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; The training group underwent a moderate intensity intermittent walking training at 60% to 80% of the 6- min-walking-test distance, four times a week of 60 min/session for a period of 10 weeks.	Behavioral: walking intervention; Moderate intensity intermittent walking training for a period of 10 weeks. The intensity of the training is 60 to 80% of 6MWTdistance. The frequency of the training is four times a week.
No Intervention: Control group; No training intervention was intended for the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum creatinine	serum concentrations of creatinine (sCr) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).	At baseline and at week 11(after the ten weeks of the training intervention).
blood urea nitrogen	serum concentrations of blood urea nitrogen (BUN) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).	At baseline and at week 11(after the ten weeks of the training intervention).
serum uric acid	serum concentrations of uric acid (sUA) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).	At baseline and at week 11(after the ten weeks of the training intervention).
glomerular Filtration Rate	the glomerular Filtration Rate (GFR) has been computed using the Cockcroft formula, as follows: GFR (mL/min) = [(140 - age) × weight ×0.85]/(sCr× 72).	At baseline and at week 11(after the ten weeks of the training intervention).
white blood cells count	blood concentration of white blood cells (WBC) count were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany)	At baseline and at week 11(after the ten weeks of the training intervention).
neutrophils	blood concentration of neutrophils (NEU) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).	At baseline and at week 11(after the ten weeks of the training intervention).
lymphocytes	blood concentrations of lymphocytes (LYM) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).	At baseline and at week 11(after the ten weeks of the training intervention).
monocytes	blood concentration of monocytes (MON) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).	At baseline and at week 11(after the ten weeks of the training intervention).
eosinophils	blood concentrations of eosinophils (EOSI) ) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).	At baseline and at week 11(after the ten weeks of the training intervention).
basophils	blood concentration of basophils (BASO) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).	At baseline and at week 11(after the ten weeks of the training intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body composition were determined, with barefoot and lightly dressed subjects, using a stadiometer (Holtain Ltd., UK) and an electronic scale (Tanita BC-533, Tokyo, Japan).	At baseline and after ten weeks of the training intervention.
6 min walking test	The 6-minute walk test was performed before and after the training intervention as an indicator of exercise capacity.	At baseline and after ten weeks of the training intervention.

Collaborators and Investigators

• Sponsor: Wissal Abassi

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): December 22, 2024
• Study Completion (Actual): December 22, 2024

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: obesity; serum creatinine; neutrophils; walking training; white blood cells; Glomerular Filtration Rate
• Other Study ID Numbers: Training and kidney

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For confidentiality reasons, all data from this study are available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No