Skip to main content
OpenTrials
Completed

NCT Number: NCT06905236

Kidney Function in Obese Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Function Tests Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Walking Intervention

Behavioral

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.

Primary outcomes

  1. serum creatinine

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    serum concentrations of creatinine (sCr) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

  2. blood urea nitrogen

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    serum concentrations of blood urea nitrogen (BUN) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

  3. serum uric acid

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    serum concentrations of uric acid (sUA) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

  4. glomerular Filtration Rate

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    the glomerular Filtration Rate (GFR) has been computed using the Cockcroft formula, as follows: GFR (mL/min) = [(140 - age) × weight ×0.85]/(sCr× 72).

  5. white blood cells count

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    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)

  6. neutrophils

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    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).

  7. lymphocytes

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    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).

  8. monocytes

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    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).

  9. eosinophils

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    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).

  10. basophils

    Time frame: At baseline and at week 11(after the ten weeks of the training intervention).

    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).

Secondary outcomes

  1. Body composition

    Time frame: At baseline and after ten weeks of the training intervention.

    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).

  2. 6 min walking test

    Time frame: At baseline and after ten weeks of the training intervention.

    The 6-minute walk test was performed before and after the training intervention as an indicator of exercise capacity.

Sponsors and collaborators

Lead sponsor

Wissal Abassi

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2025
Registry last updated
Apr 1, 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.

Related clinical trials

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