Type 2 Diabetes MellitusLifestyle InteNCT07119892
Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial
A study testing Lifestyle Modification (Exercise + Diet) in people with Type 2 Diabetes Mellitus and Inflammation, Chronic Low-Grade, run by Sinai University at 1 site in Egypt.
Trial summary
This randomized controlled trial investigated the effects of a 12-week structured lifestyle intervention-including supervised aerobic exercise and a calorie-restricted diet-on inflammatory cytokines and oxidative stress biomarkers in overweight adults with type 2 diabetes mellitus (T2DM) and moderate chronic kidney… Read more about this study
- Who is it for?
- Ages 36 to 58 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Inflammation, Chronic Low-Grade, Chronic Kidney Disease
- What is being tested?
- Lifestyle Modification (Exercise + Diet)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 25 Jun 2025
- 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 36 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following:
- Diagnosed with Type 2 Diabetes Mellitus (T2DM)
- Diagnosed with moderate chronic kidney disease (CKD Stage 3 or 4), with eGFR 25-60 mL/min/1.73 m²
- Age between 36 and 58 years
- BMI between 30-35 kg/m² (classified as obese)
- Sedentary lifestyle, defined as <30 minutes of physical activity per week over the past 6 months
- Stable medication regimen for at least 3 months
- Willing and able to provide informed consent
Who cannot join
- Participants will be excluded if they:
- Use anti-inflammatory medications regularly
- Have congestive heart failure (CHF) or coronary artery disease (CAD)
- Have moderate to severe valvular heart disease
- Have active liver disease (ALT > 3× upper normal limit)
- Have orthopedic limitations preventing exercise participation
Show all 10Show fewer
- Are currently pregnant or lactating
- Have received a kidney transplant
- Have respiratory failure or chronic pulmonary disease
- Are smokers (current) Have participated in a lifestyle intervention trial within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial investigated the effects of a 12-week structured lifestyle intervention-including supervised aerobic exercise and a calorie-restricted diet-on inflammatory cytokines and oxidative stress biomarkers in overweight adults with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD stages 3-4). A total of 60 sedentary participants aged 36-58 years were randomly assigned to either the intervention group or the control group. The primary outcomes included changes in TNF-α, IL-6, and sCRP levels. Secondary outcomes assessed oxidative stress markers (MDA, CD) and antioxidant enzymes (GSH, SOD, GPx).
Read the detailed description
Diabetic CKD is characterized by chronic low-grade inflammation and heightened oxidative stress, both of which contribute significantly to cardiovascular morbidity and kidney function decline. This study evaluated whether a 12-week structured lifestyle intervention could improve systemic inflammatory and oxidative profiles in overweight adults with T2DM and CKD stages 3-4. Participants in the intervention group underwent supervised aerobic exercise (5 sessions/week) and received individualized dietary counseling with a 1,200 kcal/day Mediterranean-style diet. The control group received standard nephrology care without lifestyle modification. Outcomes were measured pre- and post-intervention and included pro-inflammatory markers (TNF-α, IL-6, sCRP), lipid peroxidation markers (MDA, CD), and antioxidant defenses (GSH, SOD, GPx). The intervention group demonstrated statistically significant improvements in all biomarker categories compared to controls. The study supports the integration of structured lifestyle interventions into standard care for diabetic CKD patients to improve redox balance and reduce inflammatory burden.
- Conditions
- Type 2 Diabetes Mellitus, Inflammation, Chronic Low-Grade, Chronic Kidney Disease, Stage 3 Chronic Kidney Disease, Stage 4 Chronic Kidney Disease
- Being tested
- Lifestyle Modification (Exercise + Diet)
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Modification (Exercise + Diet)Behavioural
Participants received a 12-week supervised aerobic exercise program (5 sessions per week at 70% of age-predicted maximum heart rate) and dietary counseling with a calorie-restricted Mediterranean-style diet of 1,200 kcal/day. The intervention was culturally adapted, including modifications for Ramadan.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification Group (Intervention) | Experimental | Participants engaged in a 12-week supervised aerobic exercise program (5x/week) at 70% of max HR, plus a calorie-restricted Mediterranean-style diet (1,200 kcal/day). Weekly dietitian counseling included Ramadan adjustments. Receives: Behavioral: Lifestyle Modification (Exercise + Diet) |
| Standard Care Group | No intervention | Participants received routine nephrology care without structured lifestyle changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-α (pg/mL)
Change in tumor necrosis factor-alpha
Measured: Baseline and Week 12
sCRP (mg/L)
Change in serum C-reactive protein levels
Measured: Baseline and Week 12
IL-6 (pg/mL)
Change in interleukin-6 levels
Measured: Baseline and Week 12
Secondary outcomes (6)
MDA (mmol/L)
Malondialdehyde levels (oxidative stress marker)
Measured: Baseline and Week 12
CD (mmol/L)
Conjugated dienes levels
Measured: Baseline and Week 12
GSH (mmol/gHb)
Reduced glutathione level
Measured: Baseline and Week 12
GPx (units/gHb)
Glutathione peroxidase enzyme activity
Measured: Baseline and Week 12
SOD (units/mL)
Superoxide dismutase activity
Measured: Baseline and Week 12
BMI (kg/m²)
Body mass index
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Mar 2025
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119892
- Sponsor's protocol ID
- SU.REC.2025(46H)
- Acronym
- Lifestyle Inte
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07119892
- Acronym / sponsor ID
- Lifestyle Inte / SU.REC.2025(46H)
- Conditions
- Type 2 Diabetes Mellitus, Inflammation, Chronic Low-Grade, Chronic Kidney Disease, Stage 3 Chronic Kidney Disease, Stage 4 Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 13 Aug 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.
This randomized controlled trial investigated the effects of a 12-week structured lifestyle intervention-including supervised aerobic exercise and a calorie-restricted diet-on inflammatory cytokines and oxidative stress biomarkers in overweight adults with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD stages 3-4). A total of 60 sedentary participants aged 36-58 years were randomly assigned to either the intervention group or the control group. The primary outcomes included changes in TNF-α, IL-6, and sCRP levels. Secondary outcomes assessed oxidative stress markers (MDA, CD) and antioxidant enzymes (GSH, SOD, GPx).
Detailed description
Diabetic CKD is characterized by chronic low-grade inflammation and heightened oxidative stress, both of which contribute significantly to cardiovascular morbidity and kidney function decline. This study evaluated whether a 12-week structured lifestyle intervention could improve systemic inflammatory and oxidative profiles in overweight adults with T2DM and CKD stages 3-4. Participants in the intervention group underwent supervised aerobic exercise (5 sessions/week) and received individualized dietary counseling with a 1,200 kcal/day Mediterranean-style diet. The control group received standard nephrology care without lifestyle modification. Outcomes were measured pre- and post-intervention and included pro-inflammatory markers (TNF-α, IL-6, sCRP), lipid peroxidation markers (MDA, CD), and antioxidant defenses (GSH, SOD, GPx). The intervention group demonstrated statistically significant improvements in all biomarker categories compared to controls. The study supports the integration of structured lifestyle interventions into standard care for diabetic CKD patients to improve redox balance and reduce inflammatory burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification Group (Intervention) | Experimental | Behavioral: Lifestyle Modification (Exercise + Diet)Participants engaged in a 12-week supervised aerobic exercise program (5x/week) at 70% of max HR, plus a calorie-restricted Mediterranean-style diet (1,200 kcal/day). Weekly dietitian counseling included Ramadan adjustments. |
| Standard Care Group | No intervention | –Participants received routine nephrology care without structured lifestyle changes. |
Who may qualify
- Ages
- 36 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosed with Type 2 Diabetes Mellitus (T2DM)
- Diagnosed with moderate chronic kidney disease (CKD Stage 3 or 4), with eGFR 25-60 mL/min/1.73 m²
- Age between 36 and 58 years
- BMI between 30-35 kg/m² (classified as obese)
- Sedentary lifestyle, defined as <30 minutes of physical activity per week over the past 6 months
Key exclusion criteria (10 listed)
- Participants will be excluded if they:
- Use anti-inflammatory medications regularly
- Have congestive heart failure (CHF) or coronary artery disease (CAD)
- Have moderate to severe valvular heart disease
- Have active liver disease (ALT > 3× upper normal limit)
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 |
|---|---|---|
| Lifestyle Modification (Exercise + Diet)Participants received a 12-week supervised aerobic exercise program (5 sessions per week at 70% of age-predicted maximum heart rate) and dietary counseling with a calorie-restricted Mediterranean-style diet of 1,200 kcal/day. The intervention was culturally adapted, including modifications for Ramadan. | Behavioural | Lifestyle Modification Group (Intervention) |
Primary outcome
TNF-α (pg/mL)
Time frame: Baseline and Week 12
Change in tumor necrosis factor-alpha
sCRP (mg/L)
Time frame: Baseline and Week 12
Change in serum C-reactive protein levels
IL-6 (pg/mL)
Time frame: Baseline and Week 12
Change in interleukin-6 levels
6 secondary outcomes
MDA (mmol/L)
Time frame: Baseline and Week 12
CD (mmol/L)
Time frame: Baseline and Week 12
GSH (mmol/gHb)
Time frame: Baseline and Week 12
GPx (units/gHb)
Time frame: Baseline and Week 12
SOD (units/mL)
Time frame: Baseline and Week 12
BMI (kg/m²)
Time frame: Baseline and Week 12
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 17 Aug 2025.
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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. 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 Lifestyle Modification (Exercise + Diet) in people with Type 2 Diabetes Mellitus and Inflammation, Chronic Low-Grade, run by Sinai 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 8 inclusion and 10 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 17 Aug 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 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?
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?
TNF-α (pg/mL) (time frame: Baseline and Week 12). The study lists 3 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 17 Aug 2025.