Kidney Function TestsNCT06905236
Kidney Function in Obese Women
A study testing walking intervention in people with Kidney Function Tests, run by Wissal Abassi at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Kidney Function Tests
- What is being tested?
- walking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTunisia
- Study dates
- 23 Sep 2024to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
High Institute of Sports and Physical Education of Kef
Boulifa, Kef Governorate, 7100
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Function Tests
- Being tested
- walking intervention
- Keywords
- Glomerular Filtration Rate, neutrophils, obesity, serum creatinine, walking training, white blood cells
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | 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. Receives: Behavioral: walking intervention |
| Control group | No intervention | No training intervention was intended for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine
serum concentrations of creatinine (sCr) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
Secondary outcomes (2)
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).
Measured: 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.
Measured: At baseline and after ten weeks of the training intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start23 Sep 2024
- Primary completion22 Dec 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Function TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissal Abassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905236
- Sponsor's protocol ID
- Training and kidney
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Publications
Abassi W, Ouerghi N, Muscella A, Marsigliante S, Bouassida A, Feki M, Weiss K, Knechtle B. Exercise-Induced Improvements in Renal and Inflammatory Markers in Postmenopausal Women With Obesity: A Randomized Study. Womens Health Issues. 2026 Apr 21:S1049-3867(26)00063-0. doi: 10.1016/j.whi.2026.03.006. Online ahead of print.
PubMed 42020262
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Function Markers in Postmenopausal Obese Women: Response to Aerobic Training
- ClinicalTrials.gov ID
- NCT06905236
- Acronym / sponsor ID
- Training and kidney
- Conditions
- Kidney Function Tests
- Keywords
- Glomerular Filtration Rate, neutrophils, obesity, serum creatinine, walking training, white blood cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wissal AbassiUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: walking interventionThe 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. |
| Control group | No intervention | –No training intervention was intended for the control group. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking interventionModerate 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. | Behavioural | Training group |
Primary outcome
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).
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).
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).
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).
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)
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).
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).
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).
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).
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).
2 secondary outcomes
Body composition
Time frame: At baseline and after ten weeks of the training intervention.
6 min walking test
Time frame: At baseline and after ten weeks of the training intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 42020262Abassi W, Ouerghi N, Muscella A, Marsigliante S, Bouassida A, Feki M, Weiss K, Knechtle B. Exercise-Induced Improvements in Renal and Inflammatory Markers in Postmenopausal Women With Obesity: A Randomized Study. Womens Health Issues. 2026 Apr 21:S1049-3867(26)00063-0. doi: 10.1016/j.whi.2026.03.006. Online ahead of print.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
Related trials for Kidney Function Tests
Not yet recruitingPhase 2/3
N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial
Kidney Function Issue, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking intervention in people with Kidney Function Tests, run by Wissal Abassi at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine (time frame: At baseline and at week 11(after the ten weeks of the training intervention).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.