Chronic Kidney DiseaseinterventionNCT07657286
Inflammatory Cytokines and Oxidative Stress Biomarkers in Diabetic Chronic Kidney Disease Patients
A study testing aerobic treadmill exercises in people with Chronic Kidney Disease and Diabetes, run by Badr University at 1 site in Egypt.
Trial summary
This research intends to analyze how a 12-week adjustment in lifestyle influences inflammatory cytokines and oxidative stress indicators in overweight individuals diagnosed with type 2 diabetes and moderate CKD Read more about this study
- Who is it for?
- Ages 36 to 58 years
- Conditions the study is for
- Chronic Kidney Disease, Diabetes
- What is being tested?
- aerobic treadmill exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2026to 7 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 36 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sedentary lifestyle for at least three months prior to enrollment
- body mass index (BMI) of 30-35 kg/m².
Who cannot join
- using tobacco
- heart failure
- coronary arteries
- severe heart valve problems
- pregnant
- liver inflammation
Show all 9Show fewer
- kidney transplant
- physical injuries restricting them from exercising
- utilization of anti-inflammatory medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mona Mohamed Abdelkhalek
Cairo
Mona Mohamed Abdelkhalek, assistance prof, 002021024056108, 3m.sons@gmail.com
Mona mohamed Abdekhalek, assistance prof, 01024056108
About this study
Official title: Inflammatory Cytokines and Oxidative Stress Biomarkers Response to Life Style Modification in Diabetic Chronic Kidney Disease Patients
This research intends to analyze how a 12-week adjustment in lifestyle influences inflammatory cytokines and oxidative stress indicators in overweight individuals diagnosed with type 2 diabetes and moderate CKD
Read the detailed description
: 60 patients, mostly sedentary, aged 36-58 years, were diagnosed with stages 3 and 4 chronic kidney disease (eGFR 25 to 60 ml/min/1.73 m²) with concomitant type 2 diabetes and indicated body mass indexes (BMI) between 30 to 35 kg/m². The subjects were randomly assigned to two unique groups: Intervention group (Group A): Participants completed supervised aerobic treadmill exercises while sticking to a calorie-limited diet (1200 kcal/day) throughout a 12-week period. Control group (Group B): Participants received standard nephrology care without any alterations in lifestyle. In the initial phases, there was a detailed analysis of biomarkers which was later confirmed in a review conducted at the 12-week mark focusing on TNF-α, IL-6, sCRP, CD, MDA, GSH, GPx, and SOD.
- Conditions
- Chronic Kidney Disease, Diabetes
- Being tested
- aerobic treadmill exercises
- Keywords
- Diabetes; Weight Reduction; Oxidative Stress; Cytokines; Obesity.
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic treadmill exercisesOther
Also called a calorie-limited diet (1200 kcal/day)
diet (1200 kcal/day)
| Study group | Role | What they receive |
|---|---|---|
| (Group A) | Experimental | Participants completed supervised aerobic treadmill exercises while sticking to a calorie-limited diet (1200 kcal/day) throughout a 12-week period. Receives: Other: aerobic treadmill exercises |
| group (B) | No intervention | Participants received standard nephrology care without any alterations in lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDA
malondialdehyde
Measured: at baseline and after 12 WEEKS
GSH
Glutathione
Measured: at baseline and after 12 WEEKS
GPx
Glutathione peroxidase
Measured: at baseline and after 12 WEEKS
SOD
Superoxide dismutase
Measured: at baseline and after 12 WEEKS
IL-6
Interleukin-6
Measured: at baseline and after 12 WEEKS
TNF-α
tumor necrosis factor alpha
Measured: at baseline and after 12 WEEKS
CRP
C-reactive protein
Measured: at baseline and after 12 WEEKS
Secondary outcomes (1)
BMI
Body mass index
Measured: at baseline and after 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start7 Jun 2026
- Primary completion7 Sep 2026 (estimated)
- Study completion7 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Abdelkhalek, Badr University
- Investigators
- Mona Mohamed Abdelkhalek, Principal investigator, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657286
- Sponsor's protocol ID
- diabetic kidney disease
- Acronym
- intervention
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cytokines and Oxidative Stress Biomarkers Response to Life Style Modification in Diabetic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07657286
- Acronym / sponsor ID
- intervention / diabetic kidney disease
- Conditions
- Chronic Kidney Disease, Diabetes
- Keywords
- Diabetes; Weight Reduction; Oxidative Stress; Cytokines; Obesity.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 7 Jun 2026 (actual)
- Primary completion
- 7 Sep 2026 (estimated)
- Study completion
- 7 Sep 2026 (estimated)
- First posted
- 18 Jun 2026 (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.
This research intends to analyze how a 12-week adjustment in lifestyle influences inflammatory cytokines and oxidative stress indicators in overweight individuals diagnosed with type 2 diabetes and moderate CKD
Detailed description
: 60 patients, mostly sedentary, aged 36-58 years, were diagnosed with stages 3 and 4 chronic kidney disease (eGFR 25 to 60 ml/min/1.73 m²) with concomitant type 2 diabetes and indicated body mass indexes (BMI) between 30 to 35 kg/m². The subjects were randomly assigned to two unique groups: Intervention group (Group A): Participants completed supervised aerobic treadmill exercises while sticking to a calorie-limited diet (1200 kcal/day) throughout a 12-week period. Control group (Group B): Participants received standard nephrology care without any alterations in lifestyle. In the initial phases, there was a detailed analysis of biomarkers which was later confirmed in a review conducted at the 12-week mark focusing on TNF-α, IL-6, sCRP, CD, MDA, GSH, GPx, and SOD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group A) | Experimental | Other: aerobic treadmill exercisesParticipants completed supervised aerobic treadmill exercises while sticking to a calorie-limited diet (1200 kcal/day) throughout a 12-week period. |
| group (B) | No intervention | –Participants received standard nephrology care without any alterations in lifestyle. |
Who may qualify
- Ages
- 36 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- sedentary lifestyle for at least three months prior to enrollment
- body mass index (BMI) of 30-35 kg/m².
Key exclusion criteria (9 listed)
- using tobacco
- heart failure
- coronary arteries
- severe heart valve problems
- pregnant
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 |
|---|---|---|
| aerobic treadmill exercisesAlso: a calorie-limited diet (1200 kcal/day)diet (1200 kcal/day) | Other | (Group A) |
Primary outcome
MDA
Time frame: at baseline and after 12 WEEKS
malondialdehyde
GSH
Time frame: at baseline and after 12 WEEKS
Glutathione
GPx
Time frame: at baseline and after 12 WEEKS
Glutathione peroxidase
SOD
Time frame: at baseline and after 12 WEEKS
Superoxide dismutase
IL-6
Time frame: at baseline and after 12 WEEKS
Interleukin-6
TNF-α
Time frame: at baseline and after 12 WEEKS
tumor necrosis factor alpha
CRP
Time frame: at baseline and after 12 WEEKS
C-reactive protein
1 secondary outcome
BMI
Time frame: at baseline and after 12 WEEKS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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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.
Mona Mohamed Abdelkhalek principal investigator
Badr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic treadmill exercises in people with Chronic Kidney Disease and Diabetes, run by Badr University at 1 site in Egypt.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Mohamed Abdelkhalek, assistance professor (00201024056108, 3m.sons@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDA (time frame: at baseline and after 12 WEEKS). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.